Events

Alerta De Seguridad para female adapters on prosthetic feet

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

¿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
    2015-07-16
  • Fecha de publicación del evento
    2015-07-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150716_2.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: ossur female adapters on prosthetic feet medical device manufacturer, ossur, has issued a medical device safety alert concerning its female adapters on prosthetic feet. the affected devices are identified as follow: talux, vari-flex, vari-flex xc, re-flex shock, re-flex rotate cat 7 sizes 28 – 30; cat 8 sizes 25 – 30; cat 9 all sizes flex-foot assure, balance foot j cat 4 size 30; cat 5 all sizes the manufacturer’s recent findings suggest that non-össur female mating adapters connected to össur ankle male pyramids have caused early failure of the male pyramid connector. this is due to incompatible geometry of the female mating adapters used and/ or improper set up of the prosthesis. affected users are advised to follow proper set-up procedure according to the instructions for use. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 july 2015.

Device

female adapters on prosthetic feet
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ossur Female Adapters on Prosthetic Feet
  • Manufacturer
    Ossur

Manufacturer

Ossur
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    DH