Events

Rappel de Peristeen Anal Irrigation 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 Coloplast 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-00087-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-17
  • 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-00087-1
  • 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 publication of a review article on the best practice of transanal irrigation in adults, and post-market surveillance coloplast has decided to update the instructions for use. the update includes changes to the sections indication, contraindications, precautions, warnings and introduces instruction for more thorough patient examination before starting anal irrigation treatment. the potential risks that may result from the use of the device have not changed and there are no changes or modifications to the peristeen anal irrigation system.
  • Action
    Coloplast is writing to all hospitals and patients to inform them of the updates to the instructions for use. Further information on this issue has been provided on the TGA website at - http://www.tga.gov.au/safety/alerts-device-peristeen-anal-irrigation-system-140219.htm#.UwWXnbTTQgs

Device

Peristeen Anal Irrigation System
  • Modèle / numéro de série
    Peristeen Anal Irrigation SystemAll lot numbers affectedARTG Number: 135449
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd