Events

Alerta De Seguridad O Notificaciones De Seguridad para Solus Flexible Wire Reinforced Laryngeal Mask Airway

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Intersurgical.

¿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
    Safety alert / Field Safety Notice
  • Fecha
    2017-06-09
  • Fecha de publicación del evento
    2017-06-09
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/solus-flexible-wire-reinforced-laryngeal-mask-airway-risk-of-hypoxia-due-to-partial-or-total-occlusion-of-the-airway-tube-after-inflating-the-cuff
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Manufactured by intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.
  • Acción
    Identify affected devices (see below) and stop using them. Quarantine and destroy all affected devices in stock. Contact Intersurgical to acknowledge receipt of the Field Safety Notice (dated 28 March 2017) even if you don’t have affected devices left in stock.

Device

Solus Flexible Wire Reinforced Laryngeal Mask Airway
  • Modelo / Serial
  • Descripción del producto
    The following models and LOT numbers are affected:Solus Flexible, small paediatric, wire-reinforced laryngeal mask airway 2 Solus Flexible, large paediatric, wire-reinforced laryngeal mask airway 2.5 Solus Flexible, small adult, wire-reinforced laryngeal mask airway 3 Solus Flexible, medium adult, wire-reinforced laryngeal mask airway 4 Solus Flexible, large adult, wire-reinforced laryngeal mask airway 5LOT numbers: from 31310139 to 31703855 inclusive.REF numbers NHS Supply Chain Codes Scottish NDC Codes 8002001 FDD1640 n/a 8025001 FDD1641 n/a 8003001 FDD1642 NDC SKU 057290 8004001 FDD1643 NDC SKU 057306 8005001 FDD1644 n/a
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • Dirección del fabricante
    Intersurgical Ltd Telephone: 0118 9656 300 Fax: 0118 9656 356Email: info@intersurgical.co.uk
  • Empresa matriz del fabricante (2017)
    Etablissement Cosmeplast
  • Source
    MHRA