Events

Alerta De Seguridad para injectable dermal filler, Macrolane for breast augmentation

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

¿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
    2012-04-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120423d.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
    Mhra issues updates on the use of injectable dermal filler, macrolane for breast augmentation the medicines and healthcare products regulatory agency (mhra), united kingdom has issued updated information about macrolane, an injectable dermal filler manufactured by q-med. q-med has decided to discontinue macrolane for use in breast augmentation as the product may interfere with the reading of mammograms and could make diagnosis more difficult. people who have undergone breast augmentation with macrolane should inform the healthcare professional conducting their breast examination of the date of their last macrolane treatment prior to the assessment. according to the manufacturer and the mhra, there are no safety concerns with the product and the product can still be used in its other indications. according to the local supplier, the affected products have been distributed in hong kong. for details, please visit the mhra website: http://www.Mhra.Gov.Uk/newscentre/con149797 if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

injectable dermal filler, Macrolane for breast augmentation
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [23 Apr 2012] MHRA issues updates on the use of injectable dermal filler, Macrolane for breast augmentation
  • Manufacturer
    Q-MED

Manufacturer

Q-MED