Events

Alerta De Seguridad para Trak Back Pullback Device

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

¿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
    2014-09-02
  • Fecha de publicación del evento
    2014-09-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140902.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: volcano corporation trak back pullback device the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning trak back pullback device, manufactured by volcano corporation, with the following details: product code/reference no.: 91003 lot no.: all there is a concern related to the integrity of the primary pouch packaging that may impact the product sterility after shipment. should the integrity of the primary pouch packaging fail to maintain sterility of the device, the use of this device could potentially lead to the introduction of contamination into the sterile field, which could potentially lead to an adverse reaction to the patient. the manufacturer asks users to immediately cease use of the trak back ii device and return unused devices to distribution centre. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con448384 if you are in possession of the product, please contact your supplier for necessary actions. posted on 2 sep 2014.

Device

Trak Back Pullback Device
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Volcano Corporation Trak Back Pullback Device
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH