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 Origio A/S.

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 044 09 14 000
  • Date de mise en oeuvre de l'événement
    2014-09-14
  • 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=6429
  • 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 manufacturer has identified that in some cases the outer needle of double lumen needles can become detached from the handle during oocyte retrieval and also the outer needle can be twisted around the inner needle. this can lead to an increase in discomfort including more bleeding than normal for the patient during the procedure.

Device

Follicle Aspiration Set/Oocyte Retrieval
  • Modèle / numéro de série
    Product Code: FASDL1 6G, DL 16035111, DL 16035141, DL 16035641 Affected Lot Numbers: 0911FAS DL16G01, 1211FASDL16G01, 0212FASDL16G01, 0412FASDL16G01, 0512FASDL16G01, 0712FASDL16G01, 1212FASDL16G01, 0113DL1603511101, 0213DL1603511101, 0213DL1603511102, 0313DL1603511101, 0413DL1603511101, 1112DL1603514101, 0313DL1603514101, 0213DL1603564101, 0513DL1603564101
  • Description du dispositif
    Needle, aspirating oocyte, single use
  • Manufacturer
    Origio A/S

Manufacturer

Origio A/S