Events

Retiro De Equipo (Recall) de GYNEMESH PS and TVT DevicesGynemesh PS

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty 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-2015-RN-00743-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-09-02
  • 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-2015-RN-00743-1
  • 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
    Johnson & johnson medical pty. ltd. (jjm) is issuing a notification to inform hospitals and surgeons of changes to the instructions for use (ifu) for ethicon gynemesh ps and tvt devices.The changes include additional information on adverse reactions, warnings, precautions and patient selection.
  • Acción
    Johnson & Johnson Medical (JJM) is issuing a notification to inform hospitals and healthcare professionals of changes to the Instructions for Use (IFU) for Ethicon GYNEMESH PS and TVT Devices. These changes have been made following the TGA’s clinical review of urogynaecological meshes and include additional information on include additional information on adverse events, warnings and contra-indications. This action has been closed-out on 22/08/2016.

Device

GYNEMESH PS and TVT DevicesGynemesh PS
  • Modelo / Serial
    GYNEMESH PS and TVT DevicesGynemesh PSProduct Codes: GPSL and GPSXL3; TVT DevicesProduct Codes: 810041A, 810041B, 810081, TVTRL, TVTOML ARTG Number: 99193 (TVT) & 165075 (Gynemesh PS)
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd