Events

Safety Alert for Durex KY Jelly

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by manufacturer #17352.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2018-269
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525484-fda-advisory-no-2018-269
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2018-269 public health warning against the purchase and use of unregistered medical devices “durex ky jelly”.  the food and drug administration (fda) advises all concerned healthcare professionals, establishment and general consuming public against the purchase and use of durex ky jelly whose pictures appear below.  fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration. pursuant to the provision of republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of any health product that is adulterated, unregistered or misbranded are prohibited.    the abovementioned product did not undergo the evaluation process of the fda. thus, the agency cannot guarantee its quality and safety. in this regard, the public is hereby advised not to purchase the above-mentioned violative product and to be vigilant against the medical device products that are not registered with fda. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said medical device product. for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.  dissemination of the information to all concerned is requested.   attachments: fda advisory no. 2018-269.Pdf.

Device

Durex KY Jelly

Manufacturer

manufacturer #17352