The Fecal Containment Device provides a method for managing fecal incontinence. It remains securely attached to ambulatory patients. Kit contains collection device, closure clip, drainage bag adapter, powder adhesive and adhesive remover. Single use, non-sterile.
Indications for Use: The Fecal Containment Device is a method for managing fecal incontinence.
Cautions
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
This product contains natural rubber latex which may cause allergic reactions.
Liquid adhesive is flammable, keep away from fire, sparks and heated surfaces.
Check the patient's bowel status frequently.
Reassess the patients bag and anus patency at least every 2 hours. Evidence of stool or flatus should appear in
the collection bag. If not, reassess the patient lower bowel status and leg placement. Notify physician if the
condition continues.
If redness or irritation is noticeable, remove the device and the adhesive from the patient and consult a physician.
Avoid rolling the bag and putting it into a diaper or into pants. Allow the bag to hang freely; the bag may hang
through the pant leg or leg opening in the diaper.
Empty the bag before ambulating the patient.
Do not use ointments or lubricants having petrolatum base. They will damage latex device.
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted
medical practice and applicable local, state and federal laws and regulations.
Notes
Single use only.
Do not reuse.
Federal (USA) law restricts this device to sale by or on the order of a physician.
