Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por MATHYS.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 026 03 12 000
  • Fecha de inicio del evento
    2012-03-07
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1544
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The assessment of a market notification has revealed a certain insecurity in our markets regarding the correct removal of vitamys implants from the packaging. the three pouches and the sterile barrier are not clearly seen after removal of the cardboard box. this might lead to a handover to the sterile surgical staff after having opened the first pouch. as this first pouch does not represent the sterile barrier, in a worst case scenario there might be a contamination of the sterile surgical staff and surgical field.

Device

RM Pressfit cup vitamys and seleXys inlay vitamys
  • Modelo / Serial
    All lot numbers
  • Descripción del producto
    Acetabulum prosthesis
  • Manufacturer
    MATHYS

Manufacturer

MATHYS