Events

Notificaciones De Seguridad De Campo acerca de Advantage and Advantage Fit System (Transvaginal Sling) / Lynx System (Suprapubic Sling) / Obtryx System (Curved or Halo; Transobturator Sling) / Obtryx II System with PrecisionBlue Design (Curved or Halo; Transobturator Sling) / Solyx SIS System (Single Incision Sling) / Uphold LITE Vaginal Support System with Capio SLIM / Pinnacle LITE Pelvic Floor Repair Kit (Posterior with Capio SLIM) / Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device

Según Bundesinstitut für Arzneimittel und Medizinprodukte, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Germany que fue producido por Boston Scientific International S.A..

¿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
    04679/16
  • Fecha
    2016-06-13
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/04679-16_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
  • Notas adicionales en la data

Device

Advantage and Advantage Fit System (Transvaginal Sling) / Lynx System (Suprapubic Sling) / Obtryx...

Manufacturer

Boston Scientific International S.A.
  • 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
    BAM