Events

Rappel de Durolane 3ml (synovial fluid supplementation substance)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew Surgical 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-00779-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-31
  • 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-00779-1
  • 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 manufacturer has advised that there has been a higher than anticipated number of reports of post-injection knee pain and swelling. in some cases an increase in the intensity of the symptoms have been reported. pain, swelling and stiffness may limit mobility or use of the limb. recovery time might be increased and moderate to severe patient discomfort may result. some patients may have swelling due to varying degrees of effusion and which may require aspiration. most patients involved with the reported complaints recovered within the listed timeframe in the ifu and known from the clinical studies of the product. few patients had a protracted recovery time beyond 3 weeks after injection.
  • Action
    Please report any issues or adverse reactions to the TGA (refer to "Report a problem with a medical device" http://www.tga.gov.au/safety/problem.htm#device) and to Smith & Nephew Surgical. Customers with affected units are requested to advise Smith & Nephew so that replacement stock can be arranged.

Device

Durolane 3ml (synovial fluid supplementation substance)
  • Modèle / numéro de série
    Durolane 3ml (synovial fluid supplementation substance)Product Number: 1081110Batch Number: 12068-1ARTG Number: 200304
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd