Events

Retiro De Equipo (Recall) de Coban 2 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-00208-1
  • Clase de Riesgo del Evento
    Class II
  • 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-00208-1
  • 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 advised that during printing an operator error occurred where the foil used as the primary packaging for coban 2 shows "coban 2 lite" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (purple for coban 2) are correct. if coban 2 is used (rather than coban 2 lite) for a patient requiring moderate compression, a reduced blood circulation in the extremity is a possible consequence. this could lead to local necrosis or complete ischemia of the lower leg.
  • Acción
    3M Australia is advising users to inspect stock and quarantine the affected batch prior to returning to 3M.

Device

Coban 2 Compression Layer (active support bandage)
  • Modelo / Serial
    Coban 2 Compression Layer (active support bandage)Product Code: 20024ID Number: DH888822474Lot Number: 2018-12AQExpiry Date: Dec 2018ARTG Number: 235181
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

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