Events

Retiro De Equipo (Recall) de Crutches - Forearm Ergo Grip Tall and Forearm Ergo Grip Adult (one arm, walking aid crutch)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Making Life Easy Mobility And Independent Living Superstore 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-2012-RN-01036-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-05
  • 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-2012-RN-01036-1
  • 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
    Making life easy has received notification of 5 reports with the product whereby a plastic connecting arm appears to have separated from the cuff (plastic insert) of the crutch.
  • Acción
    Return affected devices to place of purchase or rental for refund or replacement. For more details, please see http://www.tga.gov.au/safety/alerts-device-mle-forearm-crutch-121213.htm

Device

Crutches - Forearm Ergo Grip Tall and Forearm Ergo Grip Adult (one arm, walking aid crutch)
  • Modelo / Serial
    Crutches - Forearm Ergo Grip Tall and Forearm Ergo Grip Adult (one arm, walking aid crutch)Crutches - Forearm Ergo Grip TallPart code: 251097Serial numbers: 1202-1 and 1203-1Crutches - Forearm Ergo Grip AdultPart code: 234354Serial numbers: 1202-1 and 1203-1ARTG Number: 138792
  • Manufacturer
    Making Life Easy Mobility And Independent Living Superstore Pty Ltd

Manufacturer

Making Life Easy Mobility And Independent Living Superstore Pty Ltd