Events

Alerta De Seguridad para ProLift S 222 Standsupport Slings

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

¿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
    2013-12-24
  • Fecha de publicación del evento
    2013-12-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131224a.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: novacare prolift s 222 standsupport slings the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning prolift s 222 standsupport slings, manufactured by novacare. details of affected products are as follows: model no.: sizes s, m and l lot no.: all production date: september 2012 according to the manufacturer, the internal quality control system has found a problem with slings produced for the prolift s222 sit-to-stand hoist as from september 2012. some slings have not been correctly sewn. the strap which holds the buckle for the back support could tear under load. this could lead to the patient falling backwards out of the hoist and therefore a high security risk exists. the manufacturer advises customers to check the production date on the sewn on label. all slings will be inspected by the manufacturer’s quality control department and either revised or replaced and then returned to customers. for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con355483 if you are in possession of the product, please contact your supplier for necessary actions. posted on 24 december 2013.

Device

ProLift S 222 Standsupport Slings
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Novacare ProLift S 222 Standsupport Slings
  • Manufacturer
    Novacare

Manufacturer

Novacare
  • Source
    DH