Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por MATHYS.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 005 10 13 000
  • Fecha de inicio del evento
    2013-10-01
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4438
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Mathys ltd bettlach (mathys) has been notified of an incident in where the optimys opening broach broke intraoperatively and the fragment was left in the bone. investigations have shown that the instrument was not used in compliance with the instructions, and detailed exploration revealed that this was causal to the incident. in the course of the investigations, it became apparent that the opening broach bent may exhibit surface defects in the hewn portion which may favor breakage in case of non-compliant usage.

Device

Bone rasp , optimys Opening Broach bent
  • Modelo / Serial
    Article number: 51.34.0079 Lot numbers: 6053731, 6054883, 6057918, 6059150, 6060683
  • Descripción del producto
    Orthopaedic surgery tools , Bone rasp , optimys Opening Broach bent
  • Manufacturer
    MATHYS

Manufacturer

MATHYS