Events

Retiro De Equipo (Recall) de ReTurnBelt wipeable

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Active Medical Supplies 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-00586-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-22
  • 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-00586-1
  • 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
    Handicare received two complaints stating that while demonstrating the function of returnbelt, when exposed to high load, the strap ripped at the heat welded seam. this action was undertaken prior to notifying the tga.
  • Acción
    Handicare AB requested all belts with the affected lot number to be returned. Handicare AB through Active Medical is refunding the amount paid.

Device

ReTurnBelt wipeable
  • Modelo / Serial
    ReTurnBelt wipeable Article Numbers: 6133,6134,6135,6136All Belts in Lot 1402SDistributed during 2014 and until March 2015ARTG Numbner: 144735
  • Manufacturer
    Active Medical Supplies Pty Ltd

Manufacturer

Active Medical Supplies Pty Ltd