Alerta De Seguridad para durolane injectable hyaluronic acid syringes

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Smith & Nephew.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Durolane Injectable Hyaluronic Acid Syringes
  • Manufacturer