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 Newdeal SAS.

¿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 091 10 11 000
  • Fecha de inicio del evento
    2011-10-30
  • 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=5&rid=970
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Newdeal sas has recently become aware that one batch of snap-off® screw dia. 2.7mm- length 20mm non sterile (catalog number 117 020 – batch ek79) has been etched and labeled with specifications of the snap-off® screw dia. 3.0mm length 20mm sterile (catalog number 117 120s – batch en5j). although we have not received any information showing that the use of such affected devices had significant consequence on patients, as a preventive measure, newdeal sas has made a decision to conduct a recall.

Device

SNAP-OFF SCREW
  • Modelo / Serial
    Diameter:2.7 mm*length 20 mm (non sterile) Diameter:3.0 mm*length 20 mm (sterile) Model: 117 020 (non sterile) and 117 120S (sterile) Lot/batch no: EK79 (117 020) EN5J (117 020S)
  • Descripción del producto
    SCREW, sterile, non sterile
  • Manufacturer
    Newdeal SAS

Manufacturer

Newdeal SAS