Events

Notificaciones De Seguridad De Campo acerca de Euphora Quick Change Balloon Dilation Catheters

Según Turkey Drugs and Medical Devices Agency (Titck), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Turkey que fue producido por Medtronic Inc.

¿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
  • ID del evento
    2017/728 & FA779
  • Fecha
    2017-07-17
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20171208225323/http://www.titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2017-728-SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data

Device

Euphora Quick Change Balloon Dilation Catheters
  • Modelo / Serial
  • Descripción del producto
    Class III
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • 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.
  • Source
    TDMDAT