Events

Alerta De Seguridad O Notificaciones De Seguridad para Prosan Flexi-T 300 intrauterine devices - batch 01A1

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Prosan International B.V..

¿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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2005/021
  • Número del evento
    CON008425
  • Fecha
    2005-03-30
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON008425
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 United Kingdom.
  • Notas adicionales en la data
  • Causa
    Detachment of control threads. mhra has received 19 reports of detachment of control threads from flexi-t 300 intrauterine devices. most of the reported incidents relate to batch number 01a1. batch details are not available for the remaining incidents. batch 01a1 was manufactured in 2001 and the last uk delivery date for this batch was 01 may 2003. the control threads may become detached on attempting to remove the device, making removal more difficult. the manufacturer issued advice to customers in 2003 and issued a reminder in january 2005 (see appendices 1 and 2). mhra is issuing this alert to ensure that all healthcare professionals involved in the placement and removal of these devices are aware of the manufacturer's advice on how to proceed in cases of difficult removal and on the use of anaesthesia. please note that the local anaesthetic described in the expert report from the manufacturer (appendix 2) is not licensed for this indication in the uk. if a local anaesthetic is necessary, please use an appropriate alternative.
  • Acción
    When removing these devices ensure that: you have read the attached information from the manufacturer you have access to small clamps for device removal in case of thread detachment. ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines. Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf

Device

Prosan Flexi-T 300 intrauterine devices - batch 01A1
  • Modelo / Serial
  • Descripción del producto
    Prosan Flexi-T 300 intrauterine devices - batch 01A1.
  • Manufacturer
    Prosan International B.V.

Manufacturer

Prosan International B.V.
  • Source
    MHRA