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 Aesculap.

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 04 18 000
  • Date de mise en oeuvre de l'événement
    2018-04-22
  • 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=12482
  • 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
    The aesculap ag received feedback from the market that the plastic sleeves of a strauss penis clamp 130mm - ef401r had stuck together after reprocessing. during complaint investigation it has been determined that the plastic sleeves of the returned instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing. internal investigation conducted at the manufacturing plant revealed that the reported failure can be limited to the production period from february 2016 to october 2017. a definite identification of an affected product is not possible without the help of suitable equipment. we therefore ask you to consider all of your existing strauss penis clamp 130mm - ef401r to be potentially affected. the results of investigation revealed that there is no increased risk expected for patients who have been treated with the affected product. according to our internal distribution information your facility received applicable unit/s manufactured within the above mentioned production period. we kindly ask you to check if an affected instrument is currently in use at your facility. in case you have located an affected product: please ensure that these instruments are no longer used.

Device

Surgical PENIS CLAMP
  • Modèle / numéro de série
    EF401R
  • Description du dispositif
    Surgical PENIS CLAMP
  • Manufacturer
    Aesculap

Manufacturer

Aesculap