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 Etac Supply Center AB.

¿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 039 03 12 000
  • Fecha de inicio del evento
    2012-03-11
  • 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=1557
  • 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
    Wheels may come off causing a risk of injury when delivered from etac the wheels are mounted on each axle and fastened with a spring-loaded ring, called a lock ring. the lock ring is placed in a groove in the axle, thereby preventing the wheels coming off. when assembling or changing the wheels it is possible to open the lock ring too much, which causes a loss of its springing quality, and can then not be fastened properly. another error may occur if the lock ring is mounted without ensuring that it fits into the groove all the way around the axle. both of these assembling errors may give the impression that the wheels are properly fastened, but such wheel can come off if it gets struck or hits an obstacle that affects the wheel sideways.

Device

Basic walker, non-foldable, Walker Avant, Avant LW, Salsa
  • Modelo / Serial
    Walker Avant, Avant LW, Salsa
  • Descripción del producto
    Walker, non-foldable
  • Manufacturer
    Etac Supply Center AB

Manufacturer

Etac Supply Center AB