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 BIONIME 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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 166 02 12 000
  • Fecha de inicio del evento
    2012-02-25
  • 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=1497
  • 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
    Potential strip vials opening in a very small amount of boxes of 100 mylife tn pura® during transportation from the warehouse in france to the pharmacies (and patients). test strips are very sensitive towards air exposure and therefore, if strips are exposed to warm and humid air in open condition, they may lose its performance (accumulated conditions: open vial + humidity + high temperature + time). the consequence may be abnormal high readings, in which case the patient may follow unsuited treatment because of inaccurate glycaemia levels and with the consequence of potential risk of hypoglycemia.

Device

Blood glucose test strip
  • Modelo / Serial
    Mylife Pura tests strip Model : GS550
  • Descripción del producto
    Test, strip, glucose
  • Manufacturer
    BIONIME Corporation

Manufacturer

BIONIME Corporation