Events

Alerta De Seguridad para Onyx Liquid Embolic System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por ev3.

¿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
    2012-07-03
  • Fecha de publicación del evento
    2012-07-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120703f.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: ev3 onyx liquid embolic system the united states food and drug administrations (fda) has issued a safety communication concerning the onyx liquid embolic system, manufactured by ev3. the fda notified physicians and patients about the risk of catheter entrapment associated with the use of onyx. catheter entrapment happens when the catheter becomes stuck in the implanted onyx material. complications of catheter entrapment include migration of the onyx plug or catheter fragment to other parts of the body, haemorrhage and death. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to fda website http://www.Fda.Gov/safety/medwatch/safetyinformation/safety alertsforhumanmedicalproducts/ucm310199.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 july 2012.

Device

Onyx Liquid Embolic System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: ev3 Onyx Liquid Embolic System
  • Manufacturer
    ev3

Manufacturer

ev3
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH