Events

Notificaciones De Seguridad De Campo acerca de S.M.A.R.T.® Flex sizes 5x200 mm and 6x200 mm

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Cordis®.

¿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
    2017-02-16
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Based on complaints and follow-up investigations, cordis found that the sizes of the 5x200 mm and 6x200 mm cordis® smart® flex cord system (a total of four part numbers) are associated with an increase in incidents involving installation problems, compared to others sizes.   the most commonly mentioned mounting problem is the inability to install the mount, which leads to an extended intervention time due to the preparation of the replacement accessory. partial placement of the abutment may also lead to ischemia or internal bleeding, which would require additional intervention.   since the launch of this product in 2013, there have been a total of three reported cases of patient injuries worldwide related to complaints of placement problems (one case of insertion bleeding and two cases of thrombus formation), which are not likely due to the use of the device. however, we cannot exclude any causal link at this time.

Device

S.M.A.R.T.® Flex sizes 5x200 mm and 6x200 mm
  • Modelo / Serial
    lot range from 34469 to 39974
  • Manufacturer
    Cordis®

Manufacturer

Cordis®