Events

Safety Alert for PARI SOLE N Inhalation Device

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by FRIWO.

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
  • Date
    2012-09-11
  • Event Date Posted
    2012-09-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120911c.html
  • Notes / Alerts
    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: power adapter used in pari sole n inhalation device the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning the power adapter manufactured by friwo used in pari sole n inhalation device. pari gmbh has received a small number of complaints regarding the mains adapter manufactured by friwo that is used with the pari sole n inhalation device. the complaints received concerned the mains adapter overheating and causing a certain part of the power adapter housing to melt. it may pose the risk of electric shock or fire. none of the reported incidents led to any personal injury or damage due to fire. the manufacturer advised users to inspect the power adapter before each use to ensure that it is not damaged. the device must not be switched on if damaged or damage is suspected. users should contact the manufacturer for replacement of the power adapter. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/ safetywarningsalertsandrecalls/fieldsafetynotices/con184398 if you are in possession of the product, please contact your supplier for necessary actions. posted on 11 september 2012.

Device

PARI SOLE N Inhalation Device
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Power Adapter used in PARI SOLE N Inhalation Device
  • Manufacturer
    FRIWO

Manufacturer

FRIWO