End User - Important Safety Information
Peristeen® empties the bowel by introducing water into the bowel using a rectal catheter. The anal irrigation procedure should always be carried out with care. Bowel perforation is an extremely rare, but serious and potentially lethal complication to anal irrigation and will require immediate admission to hospital, often requiring surgery. The risk information provided here is not comprehensive. To learn more, talk to your healthcare provided to understand the risks and benefits to determine if Peristeen is right for you. This treatment is prescribed by your physician. Although many patients benefit from the use of this device, results may vary. For further questions, call Coloplast Corp. at 1-855-605-7594 and/or consult the company website at www.coloplast.us.
Healthcare Professional - Brief Statement
The Peristeen® Anal Irrigation System is intended to instill water into the colon through a rectal catheter, which incorporates an inflatable balloon, inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen Anal Irrigation System is indicated for use by children (2 years - <12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.
Contraindications: Peristeen Anal Irrigation must not be used in the following situations:
- Known anal or colorectal stenosis
- Colorectal cancer, radiotherapy to the pelvis, and recent abdomino-perineal surgery
- Active inflammatory bowel disease, diverticulitis and ischaemic colitis
- Chronic and complex diverticular disease
- Abdominal, anal or colorectal surgery within the last 3 months
- Within 4 weeks of endoscopic polypectomy, recent colonic biopsy, recent endoscopic mucosal resection (EMR) and recent endoscopic sub-mucosal dissection (ESD)
- Severe autonomic dysreflexia, or during Spinal cord shock phase
- In patients who are pregnant and have not used the system before*
- Since the list is not exhaustive, the healthcare professional should always consider individual patient factors as well.
*If the patient is pregnant and has never used anal irrigation before, they should not start the irrigation procedure during pregnancy
Warning: Anal irrigation procedure should always be carried out with care. Bowel perforation is an extremely rare, but serious and potentially lethal complication to anal irrigation and will require immediate admission to a hospital, often requiring surgery
See the device manual for complete user instructions, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp at 1-855-605-7594 or consult the company website at www.coloplast.us
Caution: Federal law restricts this device to sale by or on the order of a physician.