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 Etac.

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 026 11 11 000
  • Date de mise en oeuvre de l'événement
    2011-11-07
  • 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=1000
  • 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
    Wheels may come off caused by assembling error of lock ring, causing a risk of injury. etac has in a ten year period had 41 registered incidents, approximately one (1) of six thousand (6000) delivered walker etac ono, involving the walker ono and wheels coming off. etac also have got information that additional incidents have occurred not reported to etac. when delivered from etac the wheels are mounted on each axle and fastened with a spring-loaded ring, called a lock ring. the lock ring is placed in a groove in the axle, thereby preventing the wheels coming off. when assembling or changing the wheels it is possible to open the lock ring too much, which causes a loss of its springing quality, and can then not be fastened properly.

Device

Walking frame, wheeled
  • Modèle / numéro de série
    Walker Ono 15041201-14 up to serial no 223000
  • Description du dispositif
    Walker
  • Manufacturer
    Etac

Manufacturer

Etac