Events

Notificaciones De Seguridad De Campo acerca de Absorb and Absorb GT1

Según Agence Fédérale des Médicaments et des Produits de Santé, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Belgium que fue producido por Abbott Vascular.

¿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
    Field Safety Notice
  • Fecha
    2015-12-02
  • País del evento
    Belgium
  • Fuente del evento
    AFMPS
  • URL de la fuente del evento
    https://www.afmps.be/fr/humain/produits_de_sante/dispositifs_medicaux/materiovigilance/fsn
  • Notas / Alertas
    Belgian data is current through November 2018. All of the data comes from the Federal Agency for Medicines and Health Products, 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 data from the U.S. and Belgium.
  • Notas adicionales en la data

Device

Absorb and Absorb GT1

Manufacturer

Abbott Vascular
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AFMPS