Events

Alerta De Seguridad para Carpentier-Edwards PERIMOUNT heart valves

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

¿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
    2012-05-29
  • Fecha de publicación del evento
    2012-05-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120529a.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 heart valves the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device field safety notice concerning the following heart valves manufactured by edward lifesciences ltd:- carpentier-edwards perimount models 2900, 6900p, and 6900ptfx, carpentier-edwards perimount magna models 3000 and 3000tfx, carpentier-edwards perimount magna ease model 3300tfx, carpentier-edwards perimount magna mitral model 7000tfx, carpentier-edwards perimount magna mitral ease model 7300tfx edwards decided to recall all unused devices with the above model numbers as they discovered that some of the valve jars containing the products may contain one or more small particles. the particles are metallic and were introduced into the valve jars during the packaging process. edwards commented that based on particle size (vast majority <200 microns in size), the small number of particles in any affected jar and the likelihood of the particles being removed during the rinse procedure described in the device’s direction for use, the risk of injury to patients implanted with an affected device is unlikely. according to the local distributor, affected products have been distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted 29 may 2012.

Device

Carpentier-Edwards PERIMOUNT heart valves
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Edwards Lifesciences Heart Valves
  • Manufacturer
    Edwards Lifesciences

Manufacturer

Edwards Lifesciences