Events

Alerte De Sécurité sur durolane injectable hyaluronic acid syringes

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Smith & Nephew.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-08-01
  • Date de publication de l'événement
    2013-08-01
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130801b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: durolane injectable hyaluronic acid syringes medical device manufacturer, smith & nephew, has issued a field safety notice concerning durolane injectable hyaluronic acid syringes with: product code: 1081110; 1082013 lot numbers: 12068-1 and 12068-2; 12133-1 the devices are manufactured by q-med ab. one of them is a smith & nephew branded product (1081110), and one is a bioventus branded product (1082013). as part of bioventus’ routine vigilance and product monitoring, they have received a higher than anticipated number of reports of post-injection knee pain and swelling and in some cases, an increase in the intensity of the symptoms reported. the health risks are as follows: immediate – pain and swelling, 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. long term – most patients involved with the reported complaints recover within the listed timeframe in the ifu and known from the clinical studies of the product. few patients have a protracted recovery time beyond 3 weeks after the injection. users are advised to quarantine affected products immediately and return them to their supplier. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 august 2013.

Device

durolane injectable hyaluronic acid syringes
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Durolane Injectable Hyaluronic Acid Syringes
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew