Flexi-Seal SIGNAL -Model FMS -Temporary Containment Device

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.