CAUTION: Rx only. USA (Federal) law restricts this device to sale by or on the order of a physician trained in the management of urinary incontinence.

INDICATION: The FemSoft Insert is indicated for the management of stress urinary incontinence in adult females.

CONTRAINDICATIONS: Not for use in women with bladder or other urinary tract infection (UTI), urethral stricture, bladder augmentation, pelvic radiation, or conditions where urethral catheterization is not clinically advisable, immunocompromised, at significant risk from UTI, interstitial cystitis, pyelonephritis, history of severely compromised urinary mucosa, unable to tolerate antibiotic treatment, on anticoagulants, overflow incontinence or neurogenic bladder.

WARNINGS/ PRECAUTIONS: Patient education and monitoring by a qualified professional is required for safe use. History of frequent UTI may increase risk of UTI. Continuous 24-hour use increases the risk of complications. Replace every 6 hours to reduce UTI risk. Discontinue for urinary, vaginal, venereal infection; hematuria; bleeding; abrasion, irritation of the bladder, urethra, urethral meatus. Mental impairment may reduce ability to use safely. Safety and efficacy have not been evaluated in pregnant women. Use of improper size could result in migration or discomfort. Do not use during sexual intercourse.

ADVERSE EVENTS, COMPLICATIONS, AND RISKS: The following adverse events have been reported with the use of the device: Bacteriuria, symptomatic UTI, urinary symptoms (including urgency, frequency, and nocturia), asymptomatic UTI, insertion trauma, bladder/urethral trauma/irritation, hematuria, spotting, vaginal yeast infection, device failure, bladder spasm, back pain, migration, pyelonephritis (possibly related to pre-existing renal stones).

Please read the FemSoft Instructions for Women and discuss it with your physician or healthcare professional.

Rochester Medical Corporation
One Rochester Medical Drive
Stewartville, MN 55976 U.S.A.
1-800-FEMSOFT (1-800-336-7638)

www.rocm.com
U.S. Patent Nos: 5,089,379; 5,269,770; 5,370,899; 5,670,111;
5,906,575; Patents Pending.

FemSoft and Rochester Medical are registered trademarks of
Rochester Medical Corporation