Events

Retiro De Equipo (Recall) de Essure Permanent Birth Control System(contraceptive device for hysteroscopic placement)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Australasian Medical & Scientific Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00825-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-20
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00825-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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)

Manufacturer

Australasian Medical & Scientific Ltd