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 Stryker.

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 094 10 11 000
  • Date de mise en oeuvre de l'événement
    2011-10-31
  • 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=973
  • 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
    There is potential for the blade to break from the arbor while the surgeon is cutting mandibular bone. the broken piece may: 1. fall into the surgical site. this may result in possible: a. delay in surgery time whilst the surgeon removes the part and obtains a replacement device the probability of occurrence is low. 2. be swallowed or aspirated into the lungs. this may result in possible: a. delay in surgery time b. tissue damage c. need for further surgery to remove the part. d. infection should the part not be removed the probability of occurrence is negligible. 3. become lodged in the mandibular bone. this may result in possible: a. delay in surgery time b. need for further surgery to remove the part c. need for x-rays and mri scans to locate the part i. mri rays may cause temporary temperature changes of the remaining implanted part. d. infection should the part not be removed the probability of occurrence is remote.

Device

Inferior Border Osteotomy (IBO) blades
  • Modèle / numéro de série
    Catalogue No: 5100-037-901; 5100-037-902; 5100-037-903; 5100-037-901S2; 5100-037-902S2 Lot No: All lots manufactured from the 31st July 31 2006 to 15th June 2011 All lots with expiry dates from 1st July 2011 to 1st July 2016
  • Description du dispositif
    IBO, blades
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Société-mère du fabricant (2017)
    Stryker
  • Représentant du fabricant
    Al-Faisaliah Medical System
  • Source
    SFDA