Events

Notificaciones De Seguridad De Campo acerca de Occlutech® Occluder Set Inventory

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Occlutech GmbH.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-01-23
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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