Events

Rappel de O2Vent T (Mandible-repositioning anti-snoring orthosis)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Oventus 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-2016-RN-01572-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-02
  • 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-2016-RN-01572-1
  • 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
    The manufacturer has determined that a correction to the adjuster assembly part of the o2vent t device is necessary and must be returned for rework. the adjuster assembly allows adjustment of the screw and hook for appropriate titration by mandibular advancement for optimised treatment. the performance of the device and risk to patient safety is affected by the faulty adhesion of the adjuster assembly part.
  • Action
    Oventus is advising clinicians to inform the patients that are using the affected product and advise them to stop using the device and arrange for it to be returned to Oventus Manufacturing for rework within 10 days. Also, any remaining devices that are currently in their possession should be also be returned for rework. This action has been closed-out on 01/03/2018.

Device

O2Vent T (Mandible-repositioning anti-snoring orthosis)
  • Modèle / numéro de série
    O2Vent T (Mandible-repositioning anti-snoring orthosis)Catalogue Number: O2VTDLDevices manufactured & delivered from 17 Nov 2016ARTG Number: 275667
  • Manufacturer
    Oventus Pty Ltd

Manufacturer

Oventus Pty Ltd