Events

Alerta De Seguridad para Oto-Ease ear lubricant

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Westone Laboratories.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2011-10-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111021.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Press release: Safety alert on ear lubricant
  • Manufacturer
    Westone Laboratories

Manufacturer

Westone Laboratories