Safety Alert for Brilliant Mouth Mirror No. 4

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Hager & Werken GmbH & Company KG.

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
    2012-05-09
  • Event Date Posted
    2012-05-09
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • 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: hager & werken brilliant mouth mirror no. 4 the medicine and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning brilliant mouth mirror no.4, manufactured by hager & werken gmbh & company kg. the manufacturer is recalling its mouth mirrors no.4 with the item code 605400 and lot number md-4/31. the mirrors could mistakenly be removed out of the frame, if this occurred it could lead to a significant risk to the patients. 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 products, please contact your supplier for necessary actions. posted on 09 may 2012.

Device

Manufacturer