Events

Alerta De Seguridad O Notificaciones De Seguridad para Synthes trauma external fixation system (small, medium, distraction osteogenesis (DO) ring and large)

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por DePuy Synthes.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2014/030
  • Número del evento
    CON437740
  • Fecha
    2014-07-23
  • Fecha de publicación del evento
    2014-07-23
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON437740?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    The instructions for use have changed. these devices are now identified as being ‘mr-conditional’. this places additional restrictions on patient positioning. failure to follow the updated instructions may result in patient harm. depuy synthes issued a second field safety notice (fsn) dated 4 july 2014, which is an extension to their original field safety notice (fsn) dated 14 april 2014.
  • Acción
    Identify affected devices using the information provided in the manufacturer’s FSNs dated 14 April  2014 and 4 July 2014 Download or request from the manufacturer a copy of the new instructions for use. Ensure that relevant staff are made aware of the changes. Ensure that all DePuy Synthes external fixation products etched ‘MR-Safe’ are considered as MR-Conditional and used in accordance with the updated MR-Conditional labelling. Return the manufacturer’s verification form. Medical directors Orthopaedic departments Orthopaedic surgeons Staff involved in the management of patients with external fixation system MR radiographers Radiologists

Device

Synthes trauma external fixation system (small, medium, distraction osteogenesis (DO) ring and la...
  • Modelo / Serial
  • Descripción del producto
    External fixators. Synthes trauma external fixation system (small, medium, distraction osteogenesis (DO) ring and large) Specific part numbers affected.
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes