Events

Retiro De Equipo (Recall) de Coban 2 Lite Compression Layer (active support bandage)

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-2016-RN-00207-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-02-24
  • 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-2016-RN-00207-1
  • 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 has identified that during printing an operator error occurred where the foil used as the primary packaging for coban 2 lite shows "coban 2" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (green for coban 2 lite) is correct. if coban 2 lite is used by mistake for a patient requiring regular compression, the compression efficacy might not be sufficient. this would be noticed by the health care provider and corrected with the next bandage change.
  • Acción
    3M Australia is advising users to inspect stock and quarantine any affected product for return or credit. This action has been closed-out on 30/01/2017.

Device

Coban 2 Lite Compression Layer (active support bandage)
  • Modelo / Serial
    Coban 2 Lite Compression Layer (active support bandage)Product Code: 20724ID Number: DH888822441Lot Number: 2017-21APExpiry Date: Dec 2017ARTG Number: 235181
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

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