Events

Rappel de EndoBarrier Gastrointestinal Liner with Delivery System

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

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-2014-RN-01320-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-18
  • 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-2014-RN-01320-1
  • 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
    Following the assessment of the risk/benefit profile during audit by the notified body, sgs, a review of the company’s historical clinical evidence for the endobarrier has been undertaken. resulting from this review gi dynamics is updating the endobarrier’s indications for use, contraindications and possible adverse events to ensure adequate risk mitigation. the change in indication specifically aims to reflect that the obesity indication includes a restriction to patients with a body mass index (bmi) = 30 kg/m2.
  • Action
    Emergo is notifying their customers of the additional warnings, contraindications and limitations to the indications. Surgeons are advised that any patients implanted with the device contrary to the additional safety information should be monitored closely for the potential complications and adverse events. The decision to remove the EndoBarrier Gastrointestinal Liner System should take into consideration the patients clinical history in the context of the new information in the IFU. This action has been closed-out on 03/05/2016. For additional information see http://tga.gov.au/alert/endobarrier-gastrointestinal-liner-delivery-system .

Device

EndoBarrier Gastrointestinal Liner with Delivery System

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia