Contraindications: The device should not be used for more than 29 consecutive days, on patients with certain medical conditions including rectal or anal abnormalities, or on patients who have had lower large bowel or rectal surgery within the last year. Do not use on patients with indwelling rectal or anal device, delivery mechanisms, or enemas in place.
Warnings and Adverse Events: There is a potential risk of misconnections with connectors from other healthcare applications. As with the use of any rectal device, adverse events can occur including: leakage of stool, loss of anal sphincter muscle tone, pressure necrosis, infection, bowel obstruction, and perforation of the bowel. Changes to the patient including: rectal bleeding indicating possible pressure necrosis, abdominal distention, cuff migration, and rectal pain should be investigated.
Specifications subject to change without notice.
For the latest information, always check the “Instructions for Use” that comes packaged with the product. If you are a consumer seeking more information.
