Events

Retiro De Equipo (Recall) de Pressure Care Medical Mattresses and Mattress Covers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Australian Comfort Group.

¿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-01408-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-31
  • 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-01408-1
  • 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
    An issue has been identified where defective labels on the printed mattress covers at the foot of the mattress may let liquid through the cover material into the foam mattress and may produce a very low risk of contamination of the mattress. the risk of infection from this defective label to a patient is very small and very unlikely.
  • Acción
    The Comfort Group is advising customers to quarantine affected stock. Collection of affected products and replacement with unaffected goods will take place as soon as possible.

Device

Pressure Care Medical Mattresses and Mattress Covers
  • Modelo / Serial
    Pressure Care Medical Mattresses and Mattress CoversNP200 Mattress Cover onlyNP200W90E Pressure Care MattressNP200W90NE Pressure Care MattressManufactured between 01 June 2014 and 31 January 2016ARTG Numbers: 261172, 260051
  • Manufacturer
    Australian Comfort Group

Manufacturer

Australian Comfort Group