Events

Alerta De Seguridad para EMBOL-X Glide Protection System

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

¿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
    2013-10-02
  • Fecha de publicación del evento
    2013-10-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002c.html
  • 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: edwards lifesciences embol-x glide protection system the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning embol-x glide protection system manufactured by edwards lifesciences ltd. the affected model numbers are exgf24, exgf24ll, exgf24mm, exgf24ss, exgf24xl, exgf24xs. through a complaint investigation, edwards lifesciences has identified a potential health risk to patients undergoing cardio pulmonary by-pass surgery when using the embol-x glide protection system. the reported complaint involved a deformed tip of the cannula that is part of the embol-x glide protection system, this was confirmed during product evaluation. as a result, the manufacturer is recalling all lot numbers of the embol-x glide protection system cannulae that have not expired. no patient injury was reported with the use of this device. the manufacturer believes that risk of injury to patients from this issue is possible; if the defect is not noticed during preparation, when force applied to the tip during insertion or removal, it may lead to a separation and embolize. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con316301 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2013.

Device

EMBOL-X Glide Protection System

Manufacturer

Edwards Lifesciences Ltd