Events

Rappel de VAGINAL STENT INFLATABLE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COLOPLAST CANADA CORPORATION.

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
    46551
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-10-15
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    The ec certificate of all medical devices from the manufacturer silimed who is a subcontractor to coloplast has been temporarily suspended by their notified body due to particles found at the surface of some breast implants. there is no indication that these issues would pose a threat to the implanted person's safety. the suspension also affects vaginal stents placed on the market by coloplast. in line with recommendations from the authorities coloplast request that all affected devices with silimed as point of origin should be put in quarantine and that use of these devices should be ceased until further notice.

Device

VAGINAL STENT INFLATABLE
  • Modèle / numéro de série
    Model Catalog: VS3026 (Lot serial: ALL); Model Catalog: VS3022 (Lot serial: ALL); Model Catalog: VS3024 (Lot serial: ALL); Model Catalog: VS3020 (Lot serial: ALL)
  • Description du dispositif
    VAGINAL STENT - INFLATABLE
  • Manufacturer
    COLOPLAST CANADA CORPORATION

Manufacturer

COLOPLAST CANADA CORPORATION
  • Adresse du fabricant
    CONCORD
  • Société-mère du fabricant (2017)
    Coloplast A/S
  • Source
    HC