Retiro De Equipo (Recall) de Kidwalk Dynamic Mobility System, model number: KW01 (A wheeled support frame intended to assist a disabled child in walking by providing a means of support)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Otto Bock Australia 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-00669-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-13
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    The tga received an incident report and examined a kidwalk mobility aid, which had failed at the base of the mast. tga’s investigation recommended to reinforce and update three important points in the owner’s manual (instructions for use) for the kidwalk with aluminium mast supplied prior to december 2010:· considerations on re-issue of the kidwalk.· regular inspection and annual service of the kidwalk · the intended purpose of the kidwalk.
  • Acción
    Update to the Instructions for Use (IFU).

Device

  • Modelo / Serial
    Kidwalk Dynamic Mobility System, model number: KW01 (A wheeled support frame intended to assist a disabled child in walking by providing a means of support)Supplied prior to December 2010Model Number: KW01ARTG Number: 175458
  • Manufacturer

Manufacturer