Alerta De Seguridad para durolane injectable hyaluronic acid syringes

Safety alert

2013-08-01

2013-08-01

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130801b.html

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.