Events

Retiro De Equipo (Recall) de Medical Mattresses and Mattress CoversAffected Batches: with printed date of manufacture between 01 June 2014 and 31 January 2016

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Dynamx Australia T/a Macmed Healthcare.

¿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-01570-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-01
  • 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-01570-1
  • 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
    There is the potential of defective labels on the printed mattress covers at the foot of the mattress. these defective labels 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
    MacMed is requesting customers to quarantine affected stock which have not been used. Collection of affected products and replacement with unaffected goods will take place as soon as possible. For customers with mattresses already in use, MadMed will visit these customers to inspect if they have affected stock which requires replacing.

Device

Medical Mattresses and Mattress CoversAffected Batches: with printed date of manufacture between ...
  • Modelo / Serial
    Medical Mattresses and Mattress CoversAffected Batches: with printed date of manufacture between 01 June 2014 and 31 January 2016ARTG Number: 107808
  • Manufacturer
    Dynamx Australia T/a Macmed Healthcare

Manufacturer

Dynamx Australia T/a Macmed Healthcare