Events

Notificaciones De Seguridad De Campo acerca de Trix, Kettwiesel, and Trets Reh

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 Hase Bikes.

¿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
    In 2017, the following incident involving a hase bikes trailer kit was reported to us: a child seated in a trike that was being pulled as a trailer took their hands off the handlebars and touched one of the brake discs, injuring themselves. this was the first incident of its kind to be reported to hase bikes. the associated risk only applies to models without rear suspension. in response to this incident, we would like to ensure that all users are informed that children who are being pulled in the trix/ketmiesel/trets must be instructed by the accompanying adult to keep their hands on the handlebar grips at all times and never touch the brake discs or wheels. .

Device

Trix, Kettwiesel, and Trets Reh

Manufacturer

Hase Bikes
  • Source
    AMPMDRS