Events

Safety Alert for Oto-Ease ear lubricant

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

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
    2011-10-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111021.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
    Tga class ii recall: oto-ease ear lubricant the therapeutic goods administration (tga) issued a class ii recall which is related to oto-ease® ear lubricant (also called oto-ease® earmold and hearing aid lubricant). some bottles of this lubricant may be contaminated and are being recalled. tga advised that if you have a bottle of oto-ease® ear lubricant supplied between 01 may 2011 - 07 october 2011, discontinue using it immediately this product maybe contaminated and could cause a local external ear infection and in rare circumstances could, in an immune compromised person, lead to a more widespread infection such as pneumonia. the tga has assessed the likelihood of this happening to be low. according to the australian supplier, the product was not distributed in hong kong for details, please refer to tga website: http://www.Tga.Gov.Au/safety/recalls-device-oto-ease-111019.Htm. if you are in possession of the affected products, please contact your doctor or supplier for necessary actions.

Device

Oto-Ease ear lubricant
  • Model / Serial
  • Product Description
    Press release: Safety alert on ear lubricant
  • Manufacturer
    Westone Laboratories

Manufacturer

Westone Laboratories