Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Boston Scientific.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 070 02 18 000
  • Fecha de inicio del evento
    2018-02-15
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12147
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Boston scientific (bsc) has observed a gradual increasing trend in reports regarding the capio suture breakage and/or detachment of the capio suture darts from both the capio suture and the pelvic floor kit mesh assembly (uphold lite vaginal support system, pinnacle™ anterior pelvic floor repair kit, pinnacle™ lite posterior with capio slim pelvic floor repair kit).

Device

Capio™ Suture Capturing Devices (SLIM, Standard, Open Access, RP), Uphold LITE with Capio™ SLIM ...
  • Modelo / Serial
    Capio™ Suture Capturing Devices (SLIM, Standard, Open Access, RP), Uphold LITE with Capio™ SLIM Vaginal Support System, Pinnacle™ Anterior Pelvic Floor Repair Kit , and Pinnacle LITE Posterior with Capio SLIM Pelvic Floor Repair Kit
  • Descripción del producto
    Suture Capturing Device
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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.”
  • Representante del fabricante
    Gulf Medical Co.
  • Source
    SFDA