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
    2012-07-16
  • Date de publication de l'événement
    2012-07-16
  • 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/recalls_20120716.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
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Westone Laboratories Oto-Ease® ear lubricant
  • Manufacturer
    Westone Laboratories

Manufacturer

Westone Laboratories