Events

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

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par MATHYS.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 005 10 13 000
  • Date de mise en oeuvre de l'événement
    2013-10-01
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4438
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    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
  • Modèle / numéro de série
    Article number: 51.34.0079 Lot numbers: 6053731, 6054883, 6057918, 6059150, 6060683
  • Description du dispositif
    Orthopaedic surgery tools , Bone rasp , optimys Opening Broach bent
  • Manufacturer
    MATHYS

Manufacturer

MATHYS