Events

Avis De Sécurité sur Vivano® Med Abdominal Kit

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par PAUL HARTMANN AG.

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
    Field Safety Notice
  • Date
    2017-03-08
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    In our internal routine controls a deviation in the manufacturing process for the above mentioned organ protection layer has been identified. this could lead to a lower stability of the weld seams, which connects the application pockets to the pe organ protection layer. an increased mechanical load could lead to a potential risk that one of the applicator pockets could be detached. we have not received any reports of events related to this issue in connection with hartmann vivano® med abdominal kits at this time. .

Device

Vivano® Med Abdominal Kit

Manufacturer

PAUL HARTMANN AG