Events

Notificaciones De Seguridad De Campo acerca de Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por DENTSPLY Caulk.

¿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
  • Número del evento
    SN2011(19)
  • Fecha
    2011-08-10
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/dycal-radiopaque-calcium-hydroxide-composition-cavity-base-liner&id=d896f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    Dentsply has become aware that certain lots of dycal may exhibit faster setting times than is normal for these products.
  • Acción
    DENTSPLY has been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA), as one of the distributors in Ireland, O’Neill Dental Ltd., has ceased trading and there are no customer records available to assist traceability.  The IMB advises that users:  • Identify the affected devices in your facility.  • If you have affected devices, follow the manufacturer’s recommendations as outlined in the attached FSN and contact DENTSPLY to arrange for return

Device

Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner
  • Modelo / Serial
  • Descripción del producto
    Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner
  • Manufacturer
    DENTSPLY Caulk

Manufacturer

DENTSPLY Caulk