Events

Retiro De Equipo (Recall) de VariVac InLine Adjustable Vacuum Wound Drainage System with bottle

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por International Medical Research 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-2013-RN-00769-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-29
  • 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-2013-RN-00769-1
  • 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
    It has been reported that a wound drainage bottle from a varivac wound drainage set was found to be cracked or split through the green connector on the top of the bottle reservoir causing a loss in vacuum in the bottle reservoir.This recall action was carried out prior to approval of the recall strategy by the tga.
  • Acción
    All affected InLine products have returned to the distributor.

Device

VariVac InLine Adjustable Vacuum Wound Drainage System with bottle

Manufacturer

International Medical Research Pty Ltd