Events

Alerta De Seguridad para BioMatrix NeoFlex

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

¿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
    2013-08-16
  • Fecha de publicación del evento
    2013-08-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130816.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: biosensors biomatrix neoflex it has come to our attention that medical device manufacturer, biosensors, has initiated a field safety corrective action concerning its biomatrix neoflex. in specific production lots of the affected device, biosensors has received reports of hub cracking prior to or during percutaneous coronary intervention procedures. this issue is related exclusively to the delivery system hub. patients who have already been successfully implanted with an affected device are not impacted by this action. if not identified prior use, the hub cracking may potentially lead to treatment delays or complications. the manufacturer has determined that the hub cracks are associated with inconsistencies in the molding process by a single hub supplier during a limited time period in the first half of 2013. the manufacturer advises users to identify, quarantine and return affected products. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

BioMatrix NeoFlex
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Biosensors BioMatrix NeoFlex
  • Manufacturer
    Biosensors

Manufacturer

Biosensors