Events

Rappel de ESSURE PERMANENT BIRTH CONTROL SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PROVINCIAL MEDICAL SUPPLIES 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
    48250
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-01-19
  • 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
    The purpose of this communication is to provide the updated labeling for essure. this notice does not include a stock recovery or any physical changes to product currently in use or on the market. labeling changes include revised essure instructions for use (ifu) and a patient information brochure (pib) that includes a patient-doctor discussion checklist (checklist). a summary of changes to the labeling includes: 1-the addition of a boxed warning listing information on the essure confirmation test adverse events that have been reported either in clinical studies or through post market surveillance and situations where device removal may be indicated. 2-the ifu has also been updated with additional information. this includes a new section on patient counseling in addition to revisions in the sections discussing safety clinical studies instructions for use and patient management. 3-the introduction of a pib including a checklist. the pib along with the checklist is intended to be reviewed by the physician and patient to facilitate the patient's understanding of birth control options benefits and potential risks associated with the use of essure as well as what to expect during and after the essure procedure.

Device

ESSURE PERMANENT BIRTH CONTROL SYSTEM
  • Modèle / numéro de série
    Model Catalog: ESS 305 (Lot serial: All Lots)
  • Description du dispositif
    ESSURE Contraceptive Device for Hysteroscopic Placement;ESSURE PERMANENT BIRTH CONTROL SYSTEM
  • Manufacturer
    PROVINCIAL MEDICAL SUPPLIES LTD.

Manufacturer

PROVINCIAL MEDICAL SUPPLIES LTD.