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 Coloplast A/S.

¿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 035 01 11 000
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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:
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    There is a potential risk of bowel perforation during trans anal irrigation or any other device for rectal insertion in general, whether using products with or without a flange which limits insertion depth. the company do not consider that the addition of a flange would eliminate the risk. a change to the design of the product has not been pursued and risk control measures concentrate on training and the precautions and contraindications contained in the instructions for use.


  • Modelo / Serial
  • Descripción del producto
    An assembly of devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Representante del fabricante
    Al Hammad Medical Services, Riyadh, (01) 4655610
  • Source