BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT FOUND THE CUNNINGHAM CLAMP INSTRUCTIONS FOR USE NOT COMPREHENSIVE. THE PATIENT REPORTEDLY CAUGHT HIS PUBIC HAIR IN THE DEVICE DURING USE AND ATTEMPTED TO USE SCISSORS TO CUT HIS HAIR FREE. THE PATIENT CUT HIMSELF WITH HIS SCISSORS AND REPORTEDLY EXPERIENCED PAIN AND SELF-LIMITED BLEEDING. THE PATIENT WOULD LIKE THE INSTRUCTIONS TO STATE THAT THE CLAMP SHOULD BE PUT ON WHILE STANDING AND TO BE MINDFUL OF PUBIC HAIR. THE PATIENT STATED THAT NO MEDICAL INTERVENTION WAS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT FOUND THE CUNNINGHAM CLAMP INSTRUCTIONS FOR USE INCOMPREHENSIVE. THE PATIENT REPORTEDLY CAUGHT HIS PUBIC HAIR IN THE DEVICE DURING USE AND ATTEMPTED TO USE SCISSORS TO CUT HIS HAIR FREE. THE PATIENT CUT HIMSELF WITH HIS SCISSORS AND REPORTEDLY EXPERIENCED PAIN AND SELF-LIMITED BLEEDING. THE PATIENT WOULD LIKE THE INSTRUCTIONS TO STATE THAT THE CLAMP SHOULD BE PUT ON WHILE STANDING AND TO BE MINDFUL OF PUBIC HAIR. THE PATIENT STATED THAT NO MEDICAL INTERVENTION WAS REQUIRED.

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 STATES 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. THIS PRODUCT CONTAINS DRY NATURAL RUBBER. AFTER REPEATED USAGE AND PROPER MAINTENANCE, 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. WASHING INSTRUCTIONS: WASH WITH MILD (HAND) SOAP AND WARM WATER. RINSE THOROUGHLY IN COOL CLEAN WATER. GENTLY SQUEEZE FOAM TO DISCHARGE EXCESS WATER. LET UNIT AIR DRY IN COOL ENVIRONMENT AWAY FROM EXCESS HEAT OR DIRECT SUNLIGHT. DO NOT USE BLEACH, DETERGENT, HOT WATER, WASHER/DRYER OR BLOW DRYER." THE DEVICE WAS NOT RETURNED.