Events

Rappel de Medical Mattresses and Mattress CoversAffected Batches: with printed date of manufacture between 01 June 2014 and 31 January 2016

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Dynamx Australia T/a Macmed Healthcare.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01570-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-01
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01570-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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 ...
  • Modèle / numéro de série
    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