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
    2012-07-16
  • Event Date Posted
    2012-07-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120716.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: westone laboratories oto-ease® ear lubricant the united states food and drug administration (fda) has posted a safety alert concerning the recall of all sizes and packaging configurations of oto-ease® ear lubricant, manufactured by westone laboratories, inc.. from a consumer complaint, the fda found that the products are potentially contaminated with pathogenic bacteria and mold through sample analysis. the product is used for easing the insertion of custom fit ear molds and hearing instruments (including hearing aids). microbial contaminations of the product could result in infectious complications of the ear canal and surrounding tissues. no injuries or illnesses have been reported to date. the fda suggested that consumers who have any size or packaging configuration should stop using the product and contact their healthcare provider. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm311978.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 16 july 2012.

Device

Oto-Ease® ear lubricant
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Westone Laboratories Oto-Ease® ear lubricant
  • Manufacturer
    Westone Laboratories

Manufacturer

Westone Laboratories