Events

Alerta De Seguridad para coopers walking frames

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

¿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
    2012-12-07
  • Fecha de publicación del evento
    2012-12-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121207a.html
  • 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: coopers walking frames the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning coopers walking frames, manufactured by sunrise medical. the affected products had dispatch dates from 20 august to 02 october 2012 inclusive. the affected product codes were 7321c, 7323c, 7325c, 7331c, 7333c, 7335c, 7341c, 7343c, 7351c and 7353c. according to the manufacturer, there was risk of falls due to the walking frame becoming unstable. the rear screws that fasten the c-shaped lower bar to the frame may fail because of a manufacturing fault. the failure usually occurred a short time after assembly. mhra had the following advice: to identify affected devices and users should undertake a visual check of affected devices located in stores. all rear screws should be checked to ensure that they are present, not loose or broken. devices that are found to have missing, broken or damaged screws are to be quarantined and not used. users were advised to return damaged devices to the manufacturer for replacement or corrective action. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con213178 if you are in possession of the product, please contact your supplier for necessary actions. posted on 7 december 2012.

Device

coopers walking frames
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Coopers Walking frames
  • Manufacturer
    Sunrise Medical

Manufacturer

Sunrise Medical