Events

Rappel de LiquiBand FIX8 Hernia Mesh Adhesive Fixation Device

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00405-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-06
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00405-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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).
  • Action
    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
  • Modèle / numéro de série
    LiquiBand FIX8 Hernia Mesh Adhesive Fixation DeviceProduct Code: FX001ARTG Number: 233374
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd