Device typeFaecal-incontinence vaginal insert trial: A non-sterile inflatable device intended to be inserted into the vagina and inflated/deflated to assist bowel evacuation regulation, as a treatment for faecal incontinence. It consists of a semi-rigid base, an inflatable balloon, valve, and optional external tubing. The balloon is inflated to occlude the adjacent rectal lumen to prevent stool leakage, and deflated to allow normal passage of stool. The device is used for a short-term trial period (typically less than 2 weeks), and may be removed/replaced by the patient. This is a single-patient reusable device after appropriate cleaning/disinfection.
FDA categoryDynamic Rectal Control System
Device ID00815430020265
Catalog numberTR02-64EPS
AvailabilityPrescription
MRI safetyMR Conditional
Height46 Millimeter
Length70 Millimeter
Width64 Millimeter