Alerta De Seguridad para Medasil Airway (Guedel type)

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medasil Surgical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-12-15
  • Fecha de publicación del evento
    2015-12-15
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medasil airway (guedel type) the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning medasil airway (guedel type), code 38/2 size 2, manufactured by medasil surgical. the affected product identifiers are lot wh61, consignments 355 and 363, expiry 2019/03. the problem relates to a single device returned to the manufacturer by a user, in which the distal end of the airway was completely blocked. this fault represents a potential serious hazard to patient safety (i.E. suffocation) if the fault is not identified before use in patients. the manufacturer is performing an immediate recall of the affected lot of airway products. for details, please refer to the mhra website:https://www.Gov.Uk/drug-device-alerts/field-safety-notices-7-to-11-december-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 december 2015.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medasil Airway (Guedel type)
  • Manufacturer

Manufacturer