Events

Alerta De Seguridad para Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless and stented)

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Vascutek 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
    2012-08-07
  • Fecha de publicación del evento
    2012-08-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120807a.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: vascutek biplex vascular grafts and biplex biovalsalva conduits (stentless and stented) the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a field safety notice (fsn) concerning biplex vascular grafts and biplex biovalsalva conduits (stentless and stented), manufactured by vascutek ltd. vascutek issued a fsn to increase clinician awareness regarding bleeding, experienced by some customers when using biplex vascular grafts and biplex biovalsalva conduits. of total product sales, which includes biplex vascular grafts and biplex biovalsalva conduits (stentless and stented); field events of graft bleeding are recorded as 2.6%. of this 2.6 % total, 80% of reports are from one country, i.E. italy. in these cases, clinicians have experienced bleeding from graft suture holes and/or anastomoses requiring additional intervention e.G. resternotomy. bleeding and re-intervention to correct bleeding has occurred during or shortly after surgery. according to the local supplier, the affected products were not 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 on 7 august 2012.

Device

Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless and stented)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Vascutek Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless and stented)
  • Manufacturer
    Vascutek Ltd

Manufacturer

Vascutek Ltd