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
    2012-07-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20120717.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
    Press release
  • Reason
    Safety alert on ear lubricant the department of health (dh) today (july 17) drew public attention to a voluntary recall of oto-ease ear lubricant manufactured by westone laboratories, inc, in the us due to potential bacteria and mould contamination. the dh, through its routine surveillance on medical devices, noticed the recall notice issued by the firm which was posted on the website of the us food and drug administration (fda). acting on a customer complaint, the fda, through its sample analysis, found the product to be potentially contaminated with pathogenic bacteria and mould. use of the product, which is intended for easing the insertion of hearing instruments, could result in infection of the ear canal and surrounding tissue. according to the manufacturer's information, no injuries or illness related to this product have been reported so far. a dh spokesman said,"consumers of the above product should stop using it immediately. they should consult their healthcare providers if they have used the product and feel unwell or if they are in doubt." "according to the preliminary information on the fda website, the product has been exported to various places outside the us, including hong kong. the dh has immediately contacted the us manufacturer to verify the information, especially on whether the product has been distributed or sold in hong kong." the spokesman said the dh has alerted the hospital authority, private hospitals and medical professional associations to this recall notice. so far, the department has not received any report of adverse events arising from this issue but shall monitor the development of the issue. ends.

Device

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

Manufacturer

Westone Laboratories