Events

Alerte De Sécurité sur Oto-Ease ear lubricant

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Westone Laboratories.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-07-17
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/press_20120717.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert on ear lubricant
  • Manufacturer
    Westone Laboratories

Manufacturer

Westone Laboratories