Alerta De Seguridad para SPY-PHI Drape

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

¿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
    2017-06-28
  • Fecha de publicación del evento
    2017-06-28
  • 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: novadaq technologies inc. spy-phi drape medical device manufacturer, novadaq technologies inc., has issued a medical device safety alert concerning its spy-phi drape. the affected model numbers are hh2000 and hh2020. according to the manufacturer, a pinhole through the drape material was identified following use of a drape in a surgical procedure. while there have been no reports of infection submitted to the manufacturer as a result of the drape material integrity being compromised, a remote possibility exists that a compromised drape may cause harm to a patient through infection. product recall is on-going. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 june 2017.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Novadaq Technologies Inc. SPY-PHI Drape
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH