Events

Alerta De Seguridad para ebb Complete Tamponade System

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

¿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
    2015-01-15
  • Fecha de publicación del evento
    2015-01-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150115.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: clinical innovations ebb complete tamponade system medical device manufacturer, clinical innovations, has issued a medical device recall concerning ebb complete tamponade system [part number: cts-1000; lot number: 0314-f-566; 0814-f-100; 0814-f-108; 0814-v-068]. the manufacturer identified a leak may occur from the distal end of the uterine balloon after receiving six reports of uterine balloon leakage during use. a uterine balloon with a leak may not provide the anticipated tamponade effect, requiring further intervention to control postpartum haemorrhage. death could unlikely occur due to this failure mode. the affected products are being recalled. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 january 2015.

Device

ebb Complete Tamponade System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Clinical Innovations ebb Complete Tamponade System
  • Manufacturer
    Clinical Innovations

Manufacturer

Clinical Innovations