Events

Rappel de Flexi-Seal CONTROL Faecal Management 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 Convatec Australia 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-2014-RN-00507-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-08
  • 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-00507-1
  • 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
    An internal assessment of product performance, including a review of customer feedback, has confirmed that flexi-seal control faecal management system is not meeting performance requirements for this product. specifically, the auto-valve has not been consistently performing relative to the inflation and deflation of the device’s retention balloon. in the event that the auto-valve does not perform properly related to inflation and deflation of the device’s retention balloon, there is the potential that medical intervention may be necessary. in accordance with the instructions for use supplied with the flexi-sealtm controltm faecal management system, the following events could occur:- leakage of stool around the device, and peri-anal skin breakdown;- rectal/anal bleeding due to pressure necrosis or ulceration of rectal or anal mucosa;- perforation of the bowel.
  • Action
    End users are advised to stop the use of all affected devices and return all affected products to their distributor for credit or replacement with unaffected product.

Device

Flexi-Seal CONTROL Faecal Management System
  • Modèle / numéro de série
    Flexi-Seal CONTROL Faecal Management SystemProduct code: 411107All lot numbersARTG number: 163198
  • Manufacturer
    Convatec Australia Pty Ltd

Manufacturer

Convatec Australia Pty Ltd