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 Synthes Inc.

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 157 06 15 000
  • Date de mise en oeuvre de l'événement
    2015-06-29
  • 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=7876
  • 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
    The affected parts and lots of the pull reduction devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage. in the event of an intraoperative breakage a surgical delay would most likely occur. breakage of the instrument into fragments during active use could lead to a significant prolongation of surgery time as the surgeon attempts to retrieve the pieces including use of radiographic imaging to determine location and size of fragment. efforts at retrieving fragments may also require additional intraoperative maneuvers e.G. supplementary incisions that were not previously intended, leading to soft tissue damage.

Device

Pull Reduction Device
  • Modèle / numéro de série
    Manufactured prior to May 15, 2013 ( specific lot numbers are included in the Field Safety Notice )
  • Description du dispositif
    Temporal bone holder
  • Manufacturer
    Synthes Inc

Manufacturer

Synthes Inc
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Représentant du fabricant
    Isam Economic Co., Riyadh, (01) 4600846
  • Source
    SFDA