Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)

The ForConti Contix Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence. The ForConti Contix FIMS is designed to seal and help prevent the involuntary leakage of stool, liquids and gases from the rectum. ForConti Contix FIMS is for an individual with fecal incontinence that has impaired quality of life, is responsive and mentally capable to participate in their own treatment. This study is designed to evaluate the safety and effectiveness of the ForConti Contix FIMS for its intended use utilizing a baseline period of 2 weeks followed by an on-device period of using the device for 4 weeks and completed with a followup period of 2 weeks.