Notificaciones De Seguridad De Campo acerca de ASAHI Halberd

Según Inspectie Gezondheidszorg en Jeugd, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Netherlands que fue producido por Asahi Intecc.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-03-07
  • País del evento
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 recall data from the U.S. and the Netherlands.
  • Notas adicionales en la data
  • Causa
    Both the box and the sterile bag of the product in question have two labels: a product label and a label indicating the outside diameter of the wire. after it appeared that a wrong outside diameter label was attached to a number of units of another product (0.018 inch instead of 0.014 inch), the production registers of comparable products with the same type of outer diameter label were checked, and it was found that the packaging of asahi halberd guidewires an incorrect outer diameter label may have been confirmed with the above lot number.

Device

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ