Events

Rappel de BRAVO - CAPSULE DELIVERY SYS

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

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
    20205
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-04-19
  • 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
    Three reports were received from customers related to patients having allergic reactions to the nickel content in the stainless steel trocar needle that attaches the bravo capsule to the esophageal mucosa. allergic reactions can include hives itching or oral numbness. there have been no reports of serious injury related to this safety notice.

Device

BRAVO - CAPSULE DELIVERY SYS
  • Modèle / numéro de série
    Model Catalog: FGS-0312 (Lot serial: all); Model Catalog: FGS-0313 (Lot serial: all)
  • Description du dispositif
    BRAVO - CAPSULE DELIVERY SYS
  • Manufacturer
    COVIDIEN

Manufacturer

COVIDIEN
  • Adresse du fabricant
    SAINT-LAURENT
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC