Events

Notificaciones De Seguridad De Campo acerca de Various devices

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 VASCUTEK Ltd.

¿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
    2017-11-30
  • 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
    This notice is to inform you about important information concerning updates to the instructions for use (ifu) for the above products. vascutek ltd has taken the opportunity to conduct a full review of the ifu contents to ensure consistency across all product families and to ensure that the instructions for use provide state of the art instruction and content to users. as a result of these updates, further clarity will be provided to clinicians regarding immersion of grafts in saline solution, and to enhance knowledge on the use of formaldehyde in the manufacturing process. further details are provided overleaf,.

Device

Various devices
  • Modelo / Serial
    Lot/Serial Number All Gelsoft^", Gelsoft™ ERS, Gelsoft™ Plus, Gelsoft™ Plus ERS, Gelseal™, Gelseal™ ERT, Gelweave™, K-Thin, K-Thin ERS, and Gelseal™ Plus Vascular Prostheses All Fluoropassiv™, Fluoropassiv™ ER, Thin Wall Fluoropassiv and Thin Wall Fluoropassiv ER Vascular Prostheses All Cardiovascular Fabric Patches All SealPTFE™ and Taperflo™ Vascular Prostheses All Lots
  • Manufacturer
    VASCUTEK Ltd

Manufacturer

VASCUTEK Ltd