Events

Safety Alert Or Field Safety Notices for Peristeen anal irrigation system

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Coloplast Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/007
  • Event Number
    CON383408
  • Date
    2014-02-26
  • Event Date Posted
    2014-02-26
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON383408?tabName=allTabs
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    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