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 Medtronic Endovascular Therapies.

¿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 120 03 14 000
  • Fecha de inicio del evento
    2014-03-25
  • 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=5540
  • 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
    Use of a fibernet eps without removal of the polyimide tube may result in vessel damage and embolic event if the polyimide tube dislodges and remains in vivo.

Device

FIBERNET® Embolic Protection System.
  • Modelo / Serial
    Model Number: FBC350500190, Lot number: 1E029174 Model Number: FBC500600190, Lot number: 1E029176 Model Number: FBC600700190, Lot number: 1E029750 Model Number: FBN350500190, Lot number:1E012912 Model Number: FBN500600190, Lot number:1E012914 Model # FBN600700190, Lot # 1E012916 and 1E017817
  • Descripción del producto
    A matrix of specially shaped PET-fibers to effectively capture arterial micro-emboli
  • Manufacturer
    Medtronic Endovascular Therapies

Manufacturer

Medtronic Endovascular Therapies
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Representante del fabricante
    Alhaya medical co., Riyadh, (011) 465 5075
  • Source
    SFDA