Events

Notificaciones De Seguridad De Campo acerca de SBK incision biopsy needle

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 Angiomed GmbH & Co. Medizintechnik KG.

¿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
  • 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
    Through complaints, angiomed has identified products with the combinations of markings and batch numbers listed in annex 1 that may contain a mandrene cap at risk of breakage. if the mandrene cap broke, the user had to remove the needle and re-insert the new needle to complete the biopsy, or abandon the biopsy completely due to certain unforeseen circumstances. our records show that your establishment has purchased one or more units of affected products with combinations of labels and batch numbers. all other products with combinations of markings and batch numbers not listed in the safety corrective action notice may continue to be used at your establishment because they are safe to use and are not subject to this product recall.

Device

SBK incision biopsy needle

Manufacturer

Angiomed GmbH & Co. Medizintechnik KG