Events

Retiro De Equipo (Recall) de Durolane 3ml (synovial fluid supplementation substance)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew Surgical Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00779-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-31
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00779-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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)
  • Modelo / Serial
    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