Events

Rappel de Essure Permanent Birth Control System(contraceptive device for hysteroscopic placement)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Australasian Medical & Scientific 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-2017-RN-00825-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-20
  • 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-2017-RN-00825-1
  • 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
    Australasian medical & scientific ltd (amsl) is issuing revised essure instructions for use (ifu) and introduced a patient information brochure (pib) that includes a patient-doctor discussion checklist.
  • Action
    A summary of changes to the labelling includes: 1. The addition of a Boxed Warning listing information on the Essure Confirmation test, reported adverse events (either from clinical studies or post market surveillance), and situations where device removal may be indicated; 2. Additional information in the IFU. This includes a new section on patient counselling, & revisions to sections discussing safety, clinical studies, instructions for use & patient management; and 3. Introduction of a PIB including a Checklist. This is intended to be reviewed by the physician & patient to facilitate the patient's understanding of birth control options, benefits & potential risks associated with the use of Essure, as well as what to expect during and after the procedure.

Device

Essure Permanent Birth Control System(contraceptive device for hysteroscopic placement)
  • Modèle / numéro de série
    Essure Permanent Birth Control System(contraceptive device for hysteroscopic placement)ARTG Number: 174123
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd