Events

Alerta De Seguridad O Notificaciones De Seguridad para Peristeen anal irrigation system

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 Coloplast Limited.

¿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/2014/007
  • Número del evento
    CON383408
  • Fecha
    2014-02-26
  • Fecha de publicación del evento
    2014-02-26
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON383408?tabName=allTabs
  • 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
    Risk of using transanal irrigation inappropriately. the manufacturer has updated the instructions for use including changes to the indications, contraindications, precautions and warning sections. more detailed instructions for patient examination before starting transanal irrigation have been added. the mhra is issuing this mda to help bring the changes to the attention of the relevant healthcare professionals, suppliers and end users.
  • Acción
    Be aware of the Field Safety Notice that Coloplast issued in January 2014. Familiarise yourself with the updated instructions for use. Review existing end users to ensure that they are aware of these changes and that the device remains suitable for their use. Amend local protocols that relate to the use of the Peristeen anal irrigation device to reflect these changes. Staff with responsibility for the procurement and supply of these products. End users of this device.

Device

Peristeen anal irrigation system
  • Modelo / Serial
  • Descripción del producto
    Peristeen anal irrigation system manufactured by Coloplast Limited. The instructions for use have been updated in response to publication of the review article ’Concensus review of best practice of transanal irrigation in adults’. Consensus review of best practice of transanal irrigation in adults (external link)
  • Manufacturer
    Coloplast Limited

Manufacturer

Coloplast Limited