BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿DIRECTION FOR EASY ADJUSTMENT TO GIVE PROPER FIT AND COMFORT 1. A VERY LIGHT PRESSURE ON THE URETHRAL CANAL ON THE UNDERSIDE OF THE PENIS WILL PREVENT ANY LEAKAGE. 2. THE NECESSARY PRESSURE IS ACHIEVED BY THE HUMP IN THE UNDER PART OF THE CUNNINGHAM CLAMP. 3. FOR PROPER FIT AND COMFORT THE UPPER PART OF THE CLAMP CAN BE EASILY SHAPED BY THE FINGERS. 4. EXACT ADJUSTMENT OF PRESSURE IS ACHIEVED BY THE RATCHET CATCH ON THE REGULAR AND LARGE SIZES AND THE ADJUSTABLE SNAP BUTTON ON THE JUVENILE SIZE. TO RELEASE THE CATCH ON THE REGULAR AND LARGE SIZES, MERELY PRESS INWARD ON BOTH THE SPRING WIRE LOOPS. 5. BE SURE THAT THE CLAMP IS NOT SET SO TIGHT THAT IT WILL INTERFERE WITH THE BLOOD CIRCULATION. JUVENILE (004052), REGULAR (004053), LARGE (004054) THIS PRODUCT CONTAINS DRY NATURAL RUBBER. FOR THE EFFECTIVE CONTROL OF ENURESIS (BED WETTING) IN MALES OF ALL AGES. AFTER REPEATED USAGE AND PROPER MAINTENANCE (SEE WASHING INSTRUCTIONS), INSPECT THE PRODUCT FOR SIGNS OF DETERIORATION OR DAMAGE (CRACKING, DISCOLORATION, SEPARATION OF FOAM). THE CLAMP SHOULD BE REPLACED EVERY 3 MONTHS, OR SOONER IF THE FOAM DETERIORATES."

Description of Event or Problem

IT WAS REPORTED THAT THE CLAMP WAS TOO SMALL AND HAD NO INSTRUCTIONS FOR USE. NO MEDICAL INTERVENTION WAS REQUIRED.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE CLAMP WAS TOO SMALL AND HAD NO INSTRUCTIONS FOR USE. NO MEDICAL INTERVENTION WAS REQUIRED.