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FDAnews Device Daily Bulletin
Jan. 7, 2011 | Vol. 8 No. 5
MHRA Warns of Bowel Perforation With Anal Irrigation
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert for Coloplast Ltd.’s Peristeen anal irrigation system to call attention to the possibility of bowel perforation caused by the insertion of the system’s rectal catheter. Bowel perforation may require surgery and can result in complications such as peritonitis or sepsis. Bowel perforation is rare and “the residual risk of perforation should be balanced against the improvement in bowel function and quality of life for each patient,” MHRA says.
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