Events

Retiro De Equipo (Recall) de LiquiBand FIX8 Hernia Mesh Adhesive Fixation Device

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life Healthcare Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00405-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-06
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00405-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Advanced medical solutions (ams) extended claims in the instructions for use of liquiband fix8 in may 2015 from "laparoscopic surgical repair of inguinal hernia, achieved through the fixation of polypropylene or polypropylene / polyester combination hernia mesh to the abdominal wall" to "laparoscopic repair of abdominal hernias, achieved through the fixation of prosthetic mesh to the abdominal wall and the approximation of peritoneum". a recent technical file audit by the notified body bsi has revealed that more data was required to support these extended claims. until further notice, the fix8 device should only be used as per the original instructions for use, version drm 06 0528 01 (revision 1).
  • Acción
    AMS is providing users with revision 1 of the IFU that is to be used with stock that has been purchased and is currently in stock. Future shipments of the device will be shipped with IFU revision 1 until further notice.

Device

LiquiBand FIX8 Hernia Mesh Adhesive Fixation Device
  • Modelo / Serial
    LiquiBand FIX8 Hernia Mesh Adhesive Fixation DeviceProduct Code: FX001ARTG Number: 233374
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd