Events

Rappel de Essure Permanent Birth Control(Australasian Medical & Scientific Ltd - ESSURE System - Contraceptive, tubal occlusion, Insert)

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-01125-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-28
  • 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-01125-1
  • 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
    Amsl is advising that all lots of essure are being removed due to a temporary suspension of the european ec certificate during the european certificate renewal process. further, post-market information suggests that some patients may not be fully informed of possible device & procedure related complications, including changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergy/hypersensitivity, or immune-type reactions.
  • Action
    AMSL is requesting customers: 1. Inspect stock and quarantine all Essure kits and then email or call AMSL to arrange for the affected stock to be recovered. This information is required to reconcile this process. 2. If any of the recalled stock could have been possibly transferred from your hospital to another, please immediately let that hospital know of the recall action. It would be appreciated if you would then telephone AMSL so contact can be made with the hospital supplied from your hospital. A summary of changes to the labelling includes: - 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. - The IFU has also been updated with additional information. This includes a new section on patient counselling in addition to revisions in the sections discussing safety, clinical studies, instructions for use and patient management. - 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. For more information, please see https://www.tga.gov.au/alert/essure-contraceptive-device

Device

Essure Permanent Birth Control(Australasian Medical & Scientific Ltd - ESSURE System - Contracept...
  • Modèle / numéro de série
    Essure Permanent Birth Control(Australasian Medical & Scientific Ltd - ESSURE System - Contraceptive, tubal occlusion, Insert)Catalogue Number/Order Code: ESS305All Batch NumbersARTG number 174123
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd