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 Caresia 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 022 05 12 000
  • Fecha de inicio del evento
    2012-05-08
  • 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=1803
  • 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 shower- and toilet chair purelift has a seat with an intimate recess and a toilet hole. the toilet hole can be covered with a lid. is the product used for toileting the lid is removed. the function of the intimate recess is to enable easier access and better cleaning while assisting toileting. it has come to caresia attention that a patient at one time (1) has pressed his thigh into the intimate recess during toileting. the patient’s thigh was caught in the intimate recess and the patients had to be helped by the staff to get his thigh free again.

Device

Bath/shower chair
  • Modelo / Serial
    Purelift 62242-00
  • Descripción del producto
    Chair, shower
  • Manufacturer
    Caresia AB

Manufacturer

Caresia AB
  • Source
    SFDA