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Consumers and health professionals are advised that Coloplast, in consultation with the TGA, has undertaken a recall for product correction for its Peristeen anal irrigation system. Specifically, this product's Instructions for Use (IFU) is being updated in response to the findings of a review of best practice for transanal irrigation for adults.
The Peristeen anal irrigation system is a medical device used to help empty the lower colon in patients who suffer from faecal incontinence, chronic constipation and/or need prolonged bowel cleansing procedures.
There are no new risks associated with using the Peristeen anal irrigation system, and there are no faults or changes to the device itself.
The IFU update includes highlighting prerequisites in the 'indications' section, and changes to the 'contraindications', 'precautions', 'warnings' and 'how to use' sections.
All Peristeen anal irrigation systems manufactured from 21 January 2014 will have the updated IFU.
Information for consumers
Coloplast has written to consumers and health professionals affected by the recall to provide further information about this issue.
There are no new risks associated with using the Peristeen anal irrigation system.
If you or someone you care for is being treated with the Peristeen anal irrigation system, contact your managing health professional for further advice.
Information for health professionals
Coloplast has written to consumers and health professionals affected by the recall to provide further information about this issue. This includes details of the IFU update and directions to disregard any previous IFU for the Peristeen anal irrigation system.
The IFU update highlights the need for thorough patient examination before starting Peristeen anal irrigation treatment in the 'indications' section, and makes additions to the 'contraindications', 'precautions' and 'warnings' sections.
The update also provides additional information in the 'how to use' section. Specifically, it directs the patient to empty their bladder before using the device and makes recommendations about avoiding overinflation of the rectal balloon.
Prior to use, patients should consult a health professional who is specialised in the use of the Peristeen anal irrigation system.
If you have any questions or concerns about the above issues, contact Coloplast on 1800 653 317.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.