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 DePuy International Limited.

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 140 05 18 000
  • Date de mise en oeuvre de l'événement
    2018-05-30
  • 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=4&rid=12696
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    A series of complaints have been received regarding debris/material being found behind the o-rings for the corail neck trials. this was evaluated through product impact assessment (pia 1125328) which concluded that this issue does not present any additional risk to the patient. however, as the ongoing investigation requires the completion of a cleaning verification study, it was considered necessary to implement interim corrective actions. the need for this has been re-iterated through discussions with the irish health authority (hpra).

Device

CORAIL AMT Neck Trials Surgical Instruments
  • Modèle / numéro de série
    L94003 - L94004 - L94005 - L94006 - L94007
  • Description du dispositif
    Non-active implantable devices
  • Manufacturer
    DePuy International Limited

Manufacturer

DePuy International Limited
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Représentant du fabricant
    Johnson & Johnson Medical Meddile East, Riyadh, (01) 4603292
  • Source
    SFDA