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 Stryker.

¿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 094 10 11 000
  • Fecha de inicio del evento
    2011-10-31
  • 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=4&rid=973
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    There is potential for the blade to break from the arbor while the surgeon is cutting mandibular bone. the broken piece may: 1. fall into the surgical site. this may result in possible: a. delay in surgery time whilst the surgeon removes the part and obtains a replacement device the probability of occurrence is low. 2. be swallowed or aspirated into the lungs. this may result in possible: a. delay in surgery time b. tissue damage c. need for further surgery to remove the part. d. infection should the part not be removed the probability of occurrence is negligible. 3. become lodged in the mandibular bone. this may result in possible: a. delay in surgery time b. need for further surgery to remove the part c. need for x-rays and mri scans to locate the part i. mri rays may cause temporary temperature changes of the remaining implanted part. d. infection should the part not be removed the probability of occurrence is remote.

Device

Inferior Border Osteotomy (IBO) blades
  • Modelo / Serial
    Catalogue No: 5100-037-901; 5100-037-902; 5100-037-903; 5100-037-901S2; 5100-037-902S2 Lot No: All lots manufactured from the 31st July 31 2006 to 15th June 2011 All lots with expiry dates from 1st July 2011 to 1st July 2016
  • Descripción del producto
    IBO, blades
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Empresa matriz del fabricante (2017)
    Stryker
  • Representante del fabricante
    Al-Faisaliah Medical System
  • Source
    SFDA