Events

Rappel de Easypod Auto Injector, model 5.1 (Used to inject SAIZEN growth hormone under the skin)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Merck Serono Australia Pty Ltd.

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-2013-RN-00908-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-04
  • 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-2013-RN-00908-1
  • 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
    The easypod injection device requires programming prior to supply to ensure the patient receives the correct dose. with the interruption in the supply of saizen solution for injection, devices required reprogramming to take into consideration the change in concentration from either 5.83 mg/ml or 8 mg/ml available in the solution for injection presentations to only 5.83 mg/ml in the click.Easy powder for injection presentation. to mitigate against the risk of a patient receiving an incorrect dose due to their device not having been reprogrammed as required, merck serono is recalling the current easypod device and replacing it with a new model. the newer model (model 5.2) will not proceed to injection if the cartridge in the device does not match the programmed settings. further, this feature cannot be over-ridden by the patient representing an improvement on the cartridge recognition feature in the current model (model 5.1).
  • Action
    Merck Serono is contacting clinicians and pharmacists of patients under the PBS Growth Hormone Program for replacing the Easypod auto injector model 5.1 with model 5.2. Merck Serono is contacting private patients affected and asking them to get the replacement devices from their pharmacies. In the meantime, customers are asked not to stop using SAIZEN and continue with the treatment as directed by their doctor. For more details, please see http://www.tga.gov.au/safety/alerts-device-easypod-auto-injector-130906.htm .

Device

Easypod Auto Injector, model 5.1 (Used to inject SAIZEN growth hormone under the skin)
  • Modèle / numéro de série
    Easypod Auto Injector, model 5.1 (Used to inject SAIZEN growth hormone under the skin)ARTG Number: 168234
  • Manufacturer
    Merck Serono Australia Pty Ltd

Manufacturer

Merck Serono Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Merck KGaA
  • Source
    DHTGA