Events

Notificaciones De Seguridad De Campo acerca de LiquiBand® FIX8

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 Advanced Medical Solutions (Plymouth) 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
    2017-03-03
  • 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
    Following further clinical evaluation by advanced medical solutions (ams), with effect from may 2015 the indications for use of the liquiband® f|x8"”i device (product) were extended from ”laparoscopic surgical repair of inguinal hernia, achieved through the fixation of polypropylene or polypropylene / polyester combination hernia mesh to the abdominal wall” to "laparoscopic repair of abdominal hernias, achieved through the fixation of prosthetic mesh to the abdominal wall and the approximation of peritoneum” (extended claims). during a recent routine technical file audit by our notified body (bsi), they confirmed that more data was required to support these extended .

Device

LiquiBand® FIX8

Manufacturer

Advanced Medical Solutions (Plymouth) Ltd