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-01554-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-05
  • 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-01554-1
  • 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 instructions for use (ifu) in relation to the adjustment range for titration is necessary. the adjustment of the screw and hook allows for appropriate titration by mandibular advancement for optimised treatment. the therapeutic treatment is unaffected by the revised adjustment range for titration. the revised adjustment range is as follows:one full turn using the adjustment key is 360 degrees. this will adjust the pitch of the screw by 0.5mm resulting in a 0.5mm titration. the screw should be adjusted a maximum of 1mm per night (i.E. 2 full turns of the adjustment key).This update only affects some patients who are currently being reviewed for optimised treatment.
  • Action
    Clinicians are advised that if their patient’s treatment has been optimised with the current positioning of their device, this correction does not affect them. They are also advised to provide a copy of the updated Instructions of Use to their patients. This action has been closed-out on 26/05/2017.

Device

O2Vent T(Mandible-repositioning anti-snoring orthosis)
  • Modèle / numéro de série
    O2Vent T(Mandible-repositioning anti-snoring orthosis)Catalogue Number: O2VTDLARTG Number: 275667
  • Manufacturer
    Oventus Pty Ltd

Manufacturer

Oventus Pty Ltd