Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: life partners easy life balloon
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning easy life balloon (reference number: elb/800-kt3.0/70 and serial numbers: all), manufactured by life partners.
some users have informed the manufacturer of partial deflation cases. there may be potential complications related to a balloon deflation: partial deflation can lead to a total deflation, causing balloon migration. the balloon could remain blocked in the digestive system and cause an obstruction which could prove to be fatal for the patient. the obstruction would need to be removed, either endoscopically or surgically.
the manufacturer has decided to stop marketing the affected intragastric balloon (since june 2013) and it is currently working on a solution to improve the levels of air tightness. it also recommends the followings:
any remaining stock of affected products should be returned.
physicians should not proceed with any new implantation of the affected products
patients should be informed on all the risks and complications related with a medical device as well as the potential additional complications which are may arise.
a regular monthly follow-up of patients should be performed and it is necessary for physicians to urgently meet the patients who currently have a balloon implanted in order to perform a radiological or endoscopic review of the balloon. each physician should judge the actions to be taken according to each patient: i.E. balloon to be maintained implanted, adjustment of balloon volume, or retrieval of balloon.
for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con394666
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 28 mar 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: medimaps tbs insight
medical device manufacturer, medimaps, has issued a medical device safety alert concerning its tbs insight [software version v.3.0.1].
the manufacturer identified a bug in v.3.0.1 when calculating the fracture-risk-assessment-tool (frax) adjusted for trabecular bone score (tbs). according to the manufacturer, the new version of tbs insight v.3.0.2 is available and will fix the following bugs:
frax adjusted for tbs: tbs insight v.3.0.2 provides correct calculation of the frax adjusted for tbs.
as a reminder, tbs insight 3.0.1 generated erroneous frax adjusted for tbs values or did not generate tbs report in the following case of vertebrae exclusions:
if (l1 & l3) or (l2 & l3) are excluded from the bone mineral density (bmd) analysis,
if l1-l4 is not entirely scanned,
if only l2 or only l3 are excluded from the bmd analysis,
when the “always use l1-l4” or “always use l2-l4” option is activated in tbs insight
apex archiving: the tbs pop-up window does not prompt during scans archiving process whatever the type of configuration used for scan detection (dxa database monitoring or folder section]. no need to close scan detector anymore.
wording improved in different languages on tbs report.
the affected customers are advised that an upgrade to v.3.0.2 has to be done as well as an impact assessment.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 9 november 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: sentreheart findrwirz guidewire system
medical device manufacturer, medimaps, has issued a medical device safety alert concerning its tbs insight [software version v.3.0.1].
the united states food and drug administration (fda) has issued medical device safety alerts concerning findrwirz guidewire system, manufactured by sentreheart [product code: 40-05; lot numbers: 01160568, 02160568 and 07160639-150; manufactured between 4 january and 22 july 2016].
the manufacturer is recalling the findrwirz guidewire system because the polytetrafluoroethylene (ptfe) coating may separate (e.G. peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients.
coating separation may be caused by issues with the device design or manufacturing processes. small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death.
affected users are recommended to take the following actions:
identify and stop using the affected products.
return the affected products to the manufacturer immediately.
for details, please refer to the fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm530413.Htm
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm530336.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 november 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: medpro accuflux elastomeric infusion pump
the united states (us) food and drug administration (fda) issued a class i recall concerning medpro accuflux elastomeric infusion pump, model ct-0020-100h, lot 91209, manufactured by medpro corporation pte ltd, singapore.
the recall was initiated because the affected lot may have a higher flow rate than specified. the use of the affected product may lead to over-administration of drug solutions to the patients. the product may fail to meet nominal flow rate of ±15%.
for details, please refer to the following fda website:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id
=60030&w=12052012&lang=eng.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 6 december 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: novacare prolift s 222 standsupport slings
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning prolift s 222 standsupport slings, manufactured by novacare. details of affected products are as follows:
model no.: sizes s, m and l
lot no.: all
production date: september 2012
according to the manufacturer, the internal quality control system has found a problem with slings produced for the prolift s222 sit-to-stand hoist as from september 2012. some slings have not been correctly sewn. the strap which holds the buckle for the back support could tear under load. this could lead to the patient falling backwards out of the hoist and therefore a high security risk exists.
the manufacturer advises customers to check the production date on the sewn on label. all slings will be inspected by the manufacturer’s quality control department and either revised or replaced and then returned to customers.
for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con355483
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 24 december 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: opus healthcare lift medical adhesive remover, 100 ml bottle
the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning lift medical adhesive remover, 100 ml, manufactured by opus healthcare, a division of alliance pharmaceuticals limited. the affected products have product code of 5501, batch code of m364 and expiry date of sep 2015.
opus healthcare is withdrawing the affected products following an observation of a “cloudy solution” of the lift medical adhesive remover which has subsequently been attributed to microbial contamination.
according to opus healthcare, there is little risk to the health of healthy individuals; however there may be a small risk of opportunistic infection developing in those whose immune systems are compromised due to illness or therapies. therefore, regardless of the appearance of the product from the affected batch, all bottles of the affected batch need to be returned.
for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con287037
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 17 july 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: pioneer surgical nubac trial inserter – 43-trl-inserter
it has come to our attention that medical device manufacturer, pioneer surgical technologies, has issued a field safety corrective action concerning nubac trial inserter – 43-trl-inserter.
the manufacturer has identified that the affected device can wear causing it not to function as designed. this wear may cause the trial spacer to become detached from the inserter while in use. if this takes place, the trial spacer may be difficult to remove from the patient which may cause patient injury during this removal process.
the manufacturer advised that the device should be inspected prior to every use and they have developed a test fixture to be used to assist in the determination of the wear of the device.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted 03 may 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: symbios gopump elastomeric infusion pumpkit
the united states food and drug administration (fda) has issued a medical device safety alert concerning gopump elastomeric infusion pumpkit manufactured by symbios medical products, llc. the affected kits, with or without accessories, are all containing dual gopump, part number 510076. these kits were distributed between 10 september 2012 and 11 february 2013.
according to the manufacturer, the products are being recalled as the flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended. this product may cause serious adverse health consequences, including death.
the manufacturer advises the affected users to immediately remove all affected gopump kits from the inventory. for details, please visit the following fda websites:
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm344311.Htm
http://www.Fda.Gov/safety/medwatch/safetyinformation/
safetyalertsforhumanmedicalproducts/ucm344352.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 19 march 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: all zenipower mercury-free hearing aid batteries
the medicines and healthcare products regulatory agency (mhra) of the united kingdom has issued an alert concerning all zenipower mercury-free hearing aid batteries manufactured by zenipower battery company limited. the affected product code numbers are as follows:
a675p mf – r44 zinc air size 675 for cochlear implants
a675 mf – r44 zinc air size 675
a13 mf – r48 zinc air size 13
a312 mf – r41 zinc air size 312
a10 mf – r70 zinc air size 10
[only batteries with best before dates of ‘08-2018’ and ‘09-2018’ are affected]
according to the mhra, the problem is caused by excessive gassing, as the zinc electrode reacts with the electrolyte to generate hydrogen. the battery may expand and possibly explode on rare occasions.
for details, please refer to the mhra website:
https://www.Gov.Uk/drug-device-alerts/all-zenipower-mercury-free-hearing-aid-batteries-low-risk-of-batteries-exploding-during-use-or-if-depleted
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 11 march 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: portable dental x-ray units
the medicines and healthcare products regulatory agency (mhra) of the united kingdom has issued a medical device alert concerning non ce-marked portable dental x-ray units including the tianjie dental falcon, manufactured by zhengzhou tianjie electronic equipment co.
according to the mhra, testing by the health protection agency (hpa) has revealed that the tianjie dental falcon device lacks sufficient shielding in the x-ray tube, which could give rise to high patient doses and under typical high radiographic workloads result in operator doses in excess of the ionising radiation regulations 1999 annual dose limits. this could give rise to adverse health effects caused by radiation.
in addition, the tianjie dental falcon portable x-ray unit is not ce-marked as a medical device and could be purchased on ebay. it is identical in appearance to a number of other non ce-marked devices that are available on the internet.
for details, please refer to the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/
index.Htm
posted on 17 july 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Removal of contraceptive device
13 december 2005 (tuesday)
the department of health (dh) has received five reports of breakage and expulsion of a batch of intra-uterine contraceptive device (iucd) in the past 12 months and women using such devices will be contacted for follow-up.
as the contraceptive effect may be affected, dh and the family planning association of hong kong (fpahk) will contact the concerned women for checkups including the removal and replacement of iucd if necessary.
a total of 1161 pieces of the iucd, of model copper t 380a and batch number fd 010201, had been used by dh's family health services and fpahk between 2001 and 2003.
the supplier of the affected device was medico techno pte ltd. of singapore .
a dh spokesman said the replacement is a precautionary measure as there has not been any report of major side effect related to using the affected iucd so far.
"in the past 12 months, fpahk has reported a total of 5 cases of the device found broken and being partially or completely expelled from the uterus. no similar occurrence has been noted in dh's clients.
"broken and expelled iucd will obviously affect contraceptive effect. women inserted with iucd should immediately consult their doctors and take other contraceptive measures if the iucds are found expelled."
"using iucd is a very effective and safe method of contraception. it carries uncommon complications such as expulsion and pelvic infection. women inserted with iucd should immediately consult their doctors if they suspect to be pregnant, or have abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge ," he added.
the spokesman reminded women inserted with all models of iucd to attend checkups regularly.
dh and fpahk are taking steps to contact their clients for follow-up.
dh has set up telephone hotlines 2961 8839 and 2961 8740 to answer public enquiries on the matter. the hotlines will operate until 9 pm today and during office hours from tomorrow. the hotline of fpahk is 2919 7725.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Removal of contraceptive device
24 december 2005 (tuesday)
the department of health (dh) had contacted all the 261 women using a same batch of copper t380a intra-uterine contraceptive device (iucd) which reported to have five incidents of breakage and expulsion in the past 12 months.
a dh spokesman said: "out of the 261 clients contacted, 51 of them have the iucds removed at dh's maternity and child care centre. all the iucd were found intact."
"dh's follow-ups also revealed no report of pregnancy arising from the breakage of iucd had been received."
dh's hotline had received a total of 204 enquiries.
the family planning association of hong kong's (fpahk) have sent out letters to all their clients and so far none reported being pregnant. a total of 59 clients have their iucds removed by fpahk. two of these iucds were found to be broken on removal.
a total of 1161 pieces of the same batch of the affected iucds were used by dh's family health services and the family planning association of hong kong (fpahk) between 2001 and 2003.
in view of the rising incidence of breakage reports, dh decided to remove the iucds from the clients as a precautionary measure.
the spokesman stressed that using iucd is a very effective and safe method of contraception. it carries uncommon complications such as expulsion and pelvic infection. women inserted with iucd should immediately consult their doctors if they suspect to be pregnant, or have abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge .
the spokesman reminded women inserted with all models of iucd to attend checkups regularly.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Dh notified of intra-uterine contraceptive device cases
18 january 2006 (wednesday)
in response to media enquiries, a spokesman for the department of health confirmed that the department has received notification from family planning association of hong kong (fpahk) that it was calling back all clients inserted with copper t 380a intra-uterine contraceptive device (iucd) for removal with or without replacement with another type of iucd.
the association observed two cases of partially broken copper t 380a iucd of batch number 60401 and decided to call back all patients concerned as precautionary measure because broken iucd could lead to reduced contraceptive efficacy.
the spokesman said that dh has alerted hospital authority, private hospitals, professional associations and medical practitioners of the incident of breakage of the batch of iucds .
so far, no serious injuries related to breakage of these iucds have been reported locally or overseas.
the spokesman said that dh did not use copper t 380a iucd of this batch. he called on women with iucds inserted should consult their doctors for advice.
“if they suspect that they are pregnant or have symptoms of abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge, they should consult their doctors immediately,” he said.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Public reminded to clean contact lens properly
the centre for health protection (chp) of the department of health today (february 18) called on members of the public to properly clean and disinfect contact lens to prevent keratitis – inflammation of the cornea of the eye.
the appeal was made following seven cases of fungal corneal infections were reported in singapore earlier this year. all of them are users of contact lens. information obtained from the singapore ministry of health indicated that of the 19 affected persons identified since may 2005, 18 used bausch and lomb's (b&l) renu multipurpose contact lens solution, a chp spokesman said. as for hong kong, the spokesman said the number of fungal kertitis cases admitted to public hospitals has remained stable in the past six months, recording a monthly average of two to three cases. "chp investigations last year revealed that some local fungal keratitis patients had also recalled using the b&l contact lens solution. "chp has earlier requested b&l manufacturer to examine its product and the company determined that the incident was not attributable to the product. sterility tests performed by the chp for samples of the products bought from local market were also negative for fungal infections," the spokesman said. in response to the recent increase in the number of cases in singapore, the chp has contacted the b&l manufacturer to obtain more update information and investigate further about possible relationship between their product and fungal keratitis cases. the chp will send letters to doctors alerting them about the situation and to be on the lookout for fungal keratitis infections. more b&l contact lens solutions will be tested for fungus and other microbes. the spokesman reminded users of soft contact lens to observe the following in the prevention of contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories;
do not wet your lens with saliva, bottled water or tap water;
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists;
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination;
all contact lenses, solutions and accessories should be stored in a cool and dry place;
disinfect the case weekly by soaking in just-boiled water for 10 minutes;
replace case every three months;
follow the instruction of cleaning and disinfection procedures by your optometrists/ophthalmologists;
discard contact lens disinfections after one month of opening;
do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists;
regular check up by your optometrists/ophthalmologists;
remove the contact lens whenever you feel discomfort or redness and seek medical advice promptly if symptoms persist despite contact lens is off; and
consult eye doctors if symptoms of keratitis developed such as eye pain, redness etc.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Update on cases of fungal corneal infections
the centre for health protection (chp) of the department of health (dh) has traced and recorded 23 cases of fungal corneal infection (keratitis) among local contact lens users following reports of this kind were found in singapore and hong kong recently.
a chp spokesman said these cases comprised six males and 17 females aged between 16 and 51. twenty of them sought medical consultations from public hospitals and three others received medical treatments in private hospitals between may 2005 and february this year. "dh has contacted 22 of these patients. twenty-one claimed that they were users of b&l renu multipurpose contact lens solution," the spokesman said. the spokesman said preliminary results of sterility tests on 20 samples of b&l renu contact lens solutions by dh are negative. "we are maintaining close communication with other agencies for further findings and developments," he said. meanwhile, dh!|s hotline has so far received more than 2 000 enquiries from members of the public. the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories;
do not wet your lens with saliva, bottled water or tap water;
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists;
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination;
all contact lenses, solutions and accessories should be stored in a cool and dry place;
disinfect the case weekly by soaking in just-boiled water for 10 minutes;
replace case every three months;
follow the instruction of cleaning and disinfection procedures by your optometrists/ophthalmologists;
discard contact lens disinfections after one month of opening;
do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists;
regular check up by your optometrists/ophthalmologists;
remove the contact lens whenever you feel discomfort or redness and seek medical advice promptly if symptoms persist despite contact lens is off; and
consult eye doctors if symptoms of keratitis developed such as eye pain, redness etc.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Update on cases of fungal corneal infections
the centre for health protection (chp) of the department of health (dh) has received four more reports of fungal corneal infection (keratitis) since early march, bringing the total number of contact lens users affected to 27 since the infection was firstly reported in may 2005.
a chp spokesman said the four recent cases comprised three males and one female aged between 17 and 43. "of the 27 patients, 26 were interviewed and 25 of them claimed that they were users of b&l renu multipurpose contact lens solution," the spokesman said. the manufacturer has voluntarily suspended sales of the contact lens solution in question from the local market since february this year as a prudent measure to protect consumers. "we are also maintaining close communication with the health authorities of singapore and the united states where cases of this kind were also reported in order to obtain the latest information and findings from them," he said. in the united states, 109 cases with suspected fungal keratitis were under investigation. of the 30 patients for whom complete data were available, 28 were soft contact lens users. twenty-six of them reported using b&l contact lens solution. in singapore, out of the 75 affected persons, 59 were sure of the contact lens solution used. of these, 56 said they had used b&l renu multipurpose contact lens solution. the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories;
attend regular check up by optometrists/ophthalmologist and follow their instructions of cleaning and disinfection procedures for contact lenses and the accessories;
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists;
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time;
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily;
all contact lens solution should be capped properly after use;
discard contact lens solutions after one month of opening;
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination;
all contact lenses, solutions and accessories should be stored in a cool and dry place;
disinfect the case weekly by soaking in just-boiled water for 10 minutes;
replace case every three months;
disposable contact lens must not be used beyond their recommended disposal period;
do not wet your lens with saliva, bottled water or tap water;
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists/ophthalmologists. seek medical advice promptly if symptoms persist despite contact lens is off.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Update on advice for prevention of fungal corneal infections
the centre for health protection (chp) of the department of health today (april 24) provides updates on cases of fungal corneal infections and advice on prevention.
in hong kong a total of 27 cases were reported to the chp since the infection was firstly reported in may 2005. of the 27 patients, 26 were interviewed and 25 of them claimed that they were users of bausch and lomb (b&l) renu multipurpose contact lens solution. the manufacturer has voluntarily suspended sales of the contact lens solution in question from the local market since february this year as a prudent measure to protect consumers. in a recent development, the us food and drug administration (fda) updated its recommendation and advise contact lens wearers to stop using b&l renu with moistureloc products, discard all remaining solution including partially used or opened bottles. the department of health echoes fda's updated recommendation and reiterates that further investigations are needed to identify the cause of the problem. "we are maintaining close communication with the health authorities in us and singapore to help determine the contributing factors and products that place contact lens users at risk for the infection," the spokesman said. the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time.
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
close all bottles of contact lens solution properly after use.
discard contact lens solutions after one month of opening.
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
all contact lenses, solutions and accessories should be stored in a cool and dry place.
disinfect the case weekly by soaking in just-boiled water for 10 minutes.
replace case every three months.
disposable contact lenses must not be used beyond their recommended disposal period.
do not wet your lens with saliva, bottled water or tap water.
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Update on cases of fungal corneal infections
the centre for health protection (chp) of the department of health (dh) has received five more reports of fungal corneal infection (keratitis) since mid-april, bringing the total number of contact lens users affected to 32 since the infection was firstly reported in may 2005.
a chp spokesman said the five recently identified cases comprised two males and three female aged between 21 and 28 who had attended public hospitals last year.
“of the 32 patients, 31 were interviewed and 29 of them claimed that they were users of b&l renu multipurpose contact lens solution.”
the manufacturer has voluntarily suspended sales of the contact lens solution in question from the local market since february this year.
“chp will continue to monitor the local situation closely,” the spokesman said.
he reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time.
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
close all bottles of contact lens solution properly after use.
discard contact lens solutions after one month of opening.
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
all contact lenses, solutions and accessories should be stored in a cool and dry place.
disinfect the case weekly by soaking in just-boiled water for 10 minutes.
replace case every three months.
disposable contact lenses must not be used beyond their recommended disposal period.
do not wet your lens with saliva, bottled water or tap water.
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Update on cases of fungal corneal infections
the centre for health protection (chp) of the department of health (dh) has received one more report of fungal corneal infection (keratitis) this month, bringing the total number of contact lens users affected to 33 since the infection was firstly reported in may 2005.
a chp spokesman said the newly identified case was a 40-year-old man who attended a public hospital in april this year.
“of the 33 patients, 32 were interviewed and 29 of them claimed that they used only b&l renu multipurpose contact lens solution,” he said.
preliminary results of case-control study conducted by the chp in connection with fungal keratitis found a significant association between development of fungual keratitis and the use of renu solution among disposable contact lens users in hong kong. the association is present even after adjusting for hygiene and other factors.
“the finding is consistent with that from a case-control study conducted in singapore,” the spokesman said.
noting that the manufacturer announced a worldwide recall of the renu with moistureloc multi-purpose contact lens solution yesterday, the spokesman said dh supported the recall and called on contact lens users to stop using the product including partially used and opened bottles.
the chp will also continue to monitor the local situation closely.
he reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time.
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
close all bottles of contact lens solution properly after use.
discard contact lens solutions after one month of opening.
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
all contact lenses, solutions and accessories should be stored in a cool and dry place.
disinfect the case weekly by soaking in just-boiled water for 10 minutes.
replace case every three months.
disposable contact lenses must not be used beyond their recommended disposal period.
do not wet your lens with saliva, bottled water or tap water.
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Serious safety concern on some medico implantable pacemakersthe department of health (dh) today (january 27) warned the public that a group of implantable pacemakers run the serious risk that they may not function.
dh, through its routine surveillance on medical devices, noticed that uk's medicines and healthcare products regulatory agency (mhra) has made an alert on a report by the italian manufacturer medico that a group of its implantable cardiac stimulators, sophos 151, sophos 155 and helios 300, might fail to function. medico discovered this during a routine follow-up and on analysis of sophos 151 pacemaker serial number mdaa473, found that the malfunctioning was because of intermittent instability of the electrical continuity of some inner substrate connections.?
a dh spokesman remarked that although the incidence of failure is low, quoted to be 0.013%, and thus far there is neither record of marketing or report of field event in hong kong, the dreaded consequence and that there may be occasional patients here who have somehow obtained the devices overseas are what cause the publication of this statement.?
the serial numbers of the medico pacemakers involved are -
a)? sophos 151, serial numbers from mdaa378 to mdaa383, from mdaa385 to mdaa411, from mdaa413 to mdaa421, mdaa423, mdaa424, from mdaa426 to mdaa448, from mdaa450 to mdaa464, from mdaa466 to mdaa472, from mdaa474 to mdaa483, from mdaa496 to mdaa506;
b)? sophos 155 with serial numbers from mdfa222 to mdfa234, from mdfa236 to mdfa312; and
c)? helios 300 with serial numbers from mb3a111 to mb3a120.
while dh will continue to check with medico and mhra about the export of the incriminated products to hong kong besides monitoring the development of the issue, the spokesman said: "any member of the public who have been implanted with any of the affected products should consult their healthcare workers for advice as soon as possible".
meanwhile, dh has also informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant.
ends/thursday, january 27, 2011.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Alert on performance of two automated external defibrillators the department of health (dh) draws public's attention to performance defects in two brands of automated external defibrillators (aeds), meducore easy and lifepak 500, made respectively by two medical device manufacturers, weinmann and medtronic, because of potential malfunctions in both.
the two incidents come to dh's notice through its surveillance system on medical device mishaps. both devices are designed for use during cardiopulmonary resuscitation.
according to weinmann, the time allotted for charging the capacitor in meducore easy is insufficient for a full charge and hence may result in device failure. the incomplete charging can be eliminated through a modification to the firmware and weinmann urges customers to send their devices to their local suppliers for upgrading.
the second incident involves lifepak 500 aed, created by physio control, a division of medtronic. it is noted that the electronic component on the main printed circuit board of a certain number of devices is susceptible to moisture, which could again cause malfunction as a result.
physio control remarks that two patients were reported as unable to be resuscitated. however, definitive causal conclusions still remain to be determined. nevertheless, the company is advising customers to contact their local service personnel for their follow-up.
dh's preliminary inquiries on the two manufacturers, including their local suppliers, reveal that while no meducore easy device has been supplied to hong kong, two lifepak 500 aeds are available locally. both are only for use in demonstrations and thus not meant for sale.
"despite the above, the possibility of possession of the above devices by individual customers cannot be ruled out and given the dreaded potential consequence of failed resuscitation, dh opts that a public announcement is warranted as a matter of prudence," a spokesman for dh explains.
so far, dh has not received any report of adverse incident related to the two brands of aeds in hong kong.
"anyone who has the aeds in question should take note of the announcement and act according to the corrective actions suggested by the manufacturers as soon as possible," the spokesman reminds the public.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Safety alert on shoulderflex massager after assessing a medical device safety alert issued by the us food and drug administration (fda) on a personal massager with the brand name “shoulderflex” distributed in the us by a company called king international, the department of health (dh) urges the local community to stop using it because of its association with strangulation or other severe injuries.
a dh spokesman remarks that the shoulderflex massager is designed for home use to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface.
"through the department's medical device surveillance scheme, we learnt that there were a few reports of either death or near-strangulation associated with shoulderflex massager in the us. according to the information available, the incidents were likely to occur when hair, clothing or jewelry became caught in the device, especially those pieces which rotated during use," the spokesman explains.
the spokesman states that the department is very concerned as the health risks could be serious even if not fatal.
"thus, in spite of the facts that the devices were mainly sold at stores or online in the us and not known to be on sale here in hong kong, nor has dh received any related notification, given the amount of travelling between the two places and also the popularity of internet trading, we consider it necessary to inform our public of the news and also advise for immediate suspension for the occasional owners," the spokesman deliberates.
finally, the spokesman adds that to be prudent, disposal of the device by owners should be in pieces so as to avoid use after reassembling.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Alert over an hiv home test kit today, the department of health (dh) advises members of the public who possess a hiv home test kit called "“accu-hiv 1 & 2 saliva test” to stop using it immediately as no known competent authority has recognised its safety and effectiveness as a diagnostic medical device.
dh tenders the above advice after assessing a health canada medical device safety alert which the department's surveillance scheme detected.
"though dh has not received any related adverse case notification nor has the product been found on sale here, because of the popularity of internet trading - a major channel for sale of the said product, dh considers it prudent to inform our public of its assessment," a dh spokesman explains.
the spokesman states that in fact, the world health organization recommends further research in the area before formulating definitive guidance on whether to promote or discourage self-testing.
"members of the public in need can call the dh's aids hotline on 2780 2211 for a free, anonymous and confidential hiv test. alternatively, they may attend our social hygiene clinics or methadone clinics (for heroin drug users); or approach individual non-governmental organisations; or consult their own family doctors for hiv testing," the spokesman advises.
"nowadays, there is growing public health concern as more and more consumers are purchasing all sorts of medical test kits through all possible channels, the internet being an increasingly important one, for use in their homes to screen, diagnose or monitor a range of health conditions. kits so marketed are usually considered as medical devices and may therefore provide as much potential benefits as risks," the spokesman gives his background remarks.
the spokesman elaborates that while there could be possible benefits like convenience, privacy and pricing, if devices are not bought from trustworthy sources, any of the following could happen -
a) they may not be of acceptable safety, effectiveness or quality;
b) they may have wrong labels and/or package inserts;
c) they might have been been distributed or stored improperly, thus tempering their safety, effectiveness or quality; and /or
d) they may even be counterfeit pieces.
"the above situations could then present the following risks to user's health -
a) not getting the medical treatment that is needed;
b) change treatment regime or lifestyle based on faulty results;
c) get incorrect diagnosis that causes needless worry, plus perhaps medical testing that is not only unnecessary, but may even present a risk of side effects; and
d) can cause direct harm to health," the spokesman illustrates.
"therefore, it is of utmost importance to realise that do-it-yourself medical tests are not a replacement for professional healthcare and they can never be. medical kits for self-testing are best used when they are part of a comprehensive programme that is supervised by a healthcare professional," the spokesman emphasizes.
"to minimise your risk, consumers should -
a) always buy their test kits from reliable sources;
b) read and follow the directions for storage. otherwise, it could affect the accuracy of the test results; and
c) check to see if there are expiry dates.
before using the kits, consumers should -
a) read the labels and directions carefully. be sure you understand exactly what you are supposed to do and follow the directions exactly as described;
b) become familiar with the limitations of the tests. be aware of what alarms and error messages mean. make sure you know what to do if the devices fail.
after conducting the test, consumers should -
a) remember that tests may not be 100% accurate. test results should always be evaluated in the context of your overall health and in consultation with qualified health care professionals;
b) do not take any action or make drastic changes to your treatment without first consulting your healthcare professionals;
c) see your healthcare attendants if you are feeling sick or worried, or if the test instructions recommend it; and
d) report any problems with kits to the trade or dh. our medical device control office does follow up on reported problems and your calls can help ensure that medical devices available here are safe, effective and of quality," the spokesman concludes.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Urgent field safety notice: “choice for health” various bandages
it has come to our attention that the united kingdom medicines and healthcare products regulatory agency (mhra) has issued an urgent field safety notice regarding various bandages of the brand “choice for health”.
national health services (nhs) supply chain has been made aware by the manufacturer tiger medical products that the seal integrity of the packaging on the primary sterile pouch on some of the above products may be compromised. subsequent use may pose an increased risk of localized infection.
nhs supply chain suggests that uk users should quarantine the products and return the affected product to nhs supply chain for further investigation.
for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Field safety notice: beavers dental fg 1/2 burs
beavers dental is conducting a recall on one lot of fg 1/2 burs. according to the manufacturer, the call is being conducted as a result of a packaging error. the package labeled as fg 1/2 burs was incorrectly packaged with la 5 burs.
according to the manufacturer, there are no hong kong consignees affected by this recall.
if you are in possession of the affected products, please contact your supplier for necessary actions.