Events

Retiro De Equipo (Recall) de Gynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter

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-01186-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-10
  • 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-01186-1
  • 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
    This product is being removed from the market as stability data does not substantiate the labelled two-year shelf life of affected product.The affected units may fail prematurely before the labelled two-year shelf life. the failure may be manifested by pinhole leak, hexcap crack leak and tri-y manifold crack leak. these types of leakage may potentially result in the abortion of the procedure, temporary thermal injury to the cervix and/or vagina and in some cases additional surgical procedures.
  • Acción
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Gynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter
  • Modelo / Serial
    Gynecare Thermachoice III Thermal Balloon Ablation Silicone CatheterProduct Code: TC033All Lots from 31st November 2013 are affectedARTG Number: 97100
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd