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
    2011-10-21
  • 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_20111021.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
    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
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert on ear lubricant
  • Manufacturer
    Westone Laboratories

Manufacturer

Westone Laboratories