Events

Avis De Sécurité sur Occlutech® Occluder Set Inventory

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 Occlutech GmbH.

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
    2017-01-23
  • 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
    A customer inadvertently used an expired occlutech flex ll pusher cable and noticed doing so shortly after the implantation procedure. there was no impact on the patient, the procedure, or the product performance. occlutech occluders and compatible pusher cables are packaged together into an occlutech product set which also contains the instructions for use and the patient information card. the outer label on the occlutech product set clearly shows the expiration dates of both the occluder and the pusher cable. as these dates can differ from each other it is important to check both dates to not miss the shortest expiration date. .

Device

Occlutech® Occluder Set Inventory
  • Modèle / numéro de série
    All Lots/All Serial Numbers/All Sizes Occluders: Figulla Flex l ASD, Figulla Flex ll ASD, Figulla Flex l PFO, Figulla Flex ll PFO, Figulla Flexl UNI, Figulla Flex || UNI, Occlutech PDA Occluder, Occlutech PLD Occluder, Occlutech mVSD Occluder, Occlutech FASD Occluder All Lots/All Serial Numbers/All Sizes
  • Manufacturer
    Occlutech GmbH

Manufacturer

Occlutech GmbH