Events

Retiro De Equipo (Recall) de Futuro Quick Strap Ankle 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 3M 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-2018-RN-00116-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-19
  • 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-2018-RN-00116-1
  • 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
    The manufacturer is aware that there is natural rubber latex (1%) in the futuro quick strap ankle support. currently packaging of this product does not have an explicit caution statement in relation to latex.The existing caution statement available on this product is "caution: some individuals may be sensitive to neoprene or neoprene blend rubber. if a rash develops, discontinue use and consult a physician".Individuals that are sensitive to latex may develop an allergic reaction.No alleged medical complaints regarding this product have been received in australia during its period of distribution.This recall does not affect any other 3m products.
  • Acción
    3M is advising pharmacies to quarantine affected stock and return it to the distributor. 3M will arrange collection of affected devices from distributors.

Device

Futuro Quick Strap Ankle Support
  • Modelo / Serial
    Futuro Quick Strap Ankle Support Product Code: 47736EN3M Code: 70005091510All batch/lot numbers are affectedARTG Number: 214679
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    DHTGA