Events

Alerte Ou Avis De Sécurité sur Peristeen anal irrigation system

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Coloplast Limited.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2014/007
  • Numéro de l'événement
    CON383408
  • Date
    2014-02-26
  • Date de publication de l'événement
    2014-02-26
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON383408?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Description du dispositif
    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