Events

Notificaciones De Seguridad De Campo acerca de Capio™ SLIM Suture Capturing Device, Capio™ SLIM Suture Capturing Device (Box 5), Capio™ Open Access Suture Capturing Device (Box 4), Capio™ Standard Suture Capturing Device (Box 4), Capio™ RP Suture Capturing Device, Uphold™ LITE with Capio™ SLIM Vaginal Support System, Pinnacle™ Anterior Pelvic Floor Repair Kit, Pinnacle™ LITE Posterior with Capio SLIM Pelvic Floor Repair Kit

Según Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Czechia que fue producido por Boston Scientific Corporation.

¿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
    1485
  • Fecha
    2018-03-16
  • País del evento
    Czechia
  • Fuente del evento
    MHSIDCCCDMIS
  • URL de la fuente del evento
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notas / Alertas
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
  • Notas adicionales en la data

Device

Capio™ SLIM Suture Capturing Device, Capio™ SLIM Suture Capturing Device (Box 5), Capio™ Open Acc...
  • Modelo / Serial
    Model Number: Capio™ SLIM Suture Capturing Device M0068318250 Capio™ SLIM Suture Capturing Device (Box 5) M0068318261 Capio™ Open Access Suture Capturing Device (Box 4) M0068311251 Capio™ Standard Suture Capturing Device (Box 4) M0068312321 Capio™ RP Suture Capturing Device M0068321010 Uphold™ LITE with Capio™ SLIM Vaginal Support System M0068318170 Pinnacle™ Anterior Pelvic Floor Repair Kit M0068317050 Pinnacle™ LITE Posterior with Capio SLIM Pelvic Floor Repair Kit M0068318150
  • Descripción del producto
    Inactive implantable medical devices
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHSIDCCCDMIS