Flexi-Seal® SIGNAL™ FMS is a temporary containment device, indicated for bedridden or immobilized, incontinent patients with liquid or semi-liquid stool. It is designed to safely and effectively contain and divert fecal matter, protect patients' wounds from fecal contamination and reduce both the risk of skin breakdown and spread of infection. This easy-to-use system provides an excellent alternative to traditional methods of managing fecal incontinence such as pads, diapers, fecal pouches, and rectal tubes. Flexi-Seal® SIGNAL™ FMS consists of a silicone catheter, a syringe, and a collection bag. At one end, the soft silicone catheter has a retention balloon that is inserted into the rectum. At the opposite end, the catheter has a connector for attaching the collection bag. The Flexi-Seal® SIGNAL™ Fecal Management System contains 1 soft silicone catheter tube assembly, 1 syringe, and 3 collection bags. United States federal law restricts this device to sale by or on the order of a physician or other health care professional.