Events

Rappel de LGX PRECONNECT WITH MS PUMP INFRAPUBIC INHIBIZONE COATED

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par AMERICAN MEDICAL SYSTEMS INC.

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
    20917
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-07-23
  • 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
    Reports from physicians and/or patients with difficulty inflating ams 700 with ms pump cylinders. this occurred either during srugical implantation or post-operatively.

Device

LGX PRECONNECT WITH MS PUMP INFRAPUBIC INHIBIZONE COATED
  • Modèle / numéro de série
    Model Catalog: 72404259 (Lot serial: all); Model Catalog: 72404280 (Lot serial: all); Model Catalog: 72404257 (Lot serial: all); Model Catalog: 72404256 (Lot serial: all); Model Catalog: 72404255 (Lot serial: all); Model Catalog: 72404209 (Lot serial: all); Model Catalog: 72404303 (Lot serial: all); Model Catalog: 72404302 (Lot serial: all); Model Catalog: 72404301 (Lot serial: all); Model Catalog: 72404300 (Lot serial: all); Model Catalog: 72404239 (Lot serial: all); Model Catalog: 72404238 (Lot serial: all); Model Catalog: 72404237 (Lot serial: all); Model Catalog: 72404236 (Lot serial: all); Model Catalog: 72404235 (Lot serial: all); Model Catalog: 72404289 (Lot serial: all); Model Catalog: 72404288 (Lot serial: all); Model Catalog: 72404287 (Lot serial: all); Model Catalog: 72404286 (Lot serial: all); Model Catalog: 72404285 (Lot serial: all); Model Catalog: 72404269 (Lot serial: all); Model Catalog: 72404268 (Lot serial: all); Model Catalog: 72404267 (Lot serial: all); Model Catalog: 72404266 (Lot seria
  • Description du dispositif
    LGX PRECONNECT WITH MS PUMP INFRAPUBIC WITH INHIBIZONE
  • Manufacturer
    AMERICAN MEDICAL SYSTEMS INC

Manufacturer

AMERICAN MEDICAL SYSTEMS INC
  • Adresse du fabricant
    MINNETONKA
  • Source
    HC