BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED. THE SAMPLE DID NOT SHOW ANY RESULTING SKIN IRRITATION. THE PATIENT-DEVICE INCOMPATIBILITY COULD NOT BE ASSESSED. THE VISUAL INSPECTION OF THE SAMPLE NOTED THAT THE SAMPLE RECEIVED MET SPECIFICATIONS. THE DEVICE HEIGHT HAD BEEN REDUCED AS A RESULT OF THE UPPER CLAMP BEING DISPLACED, WHICH IS CONSIDERED NORMAL WEAR. THE CLAMP IS DESIGNED TO BE SHAPED BY THE USER TO ENSURE PROPER FIT AND COMFORT UPON INITIAL USE AND IN RESPONSE TO NORMAL WEAR. NO SHARP AND/OR IRREGULAR AREAS WERE OBSERVED. BASED ON THE INVESTIGATION FINDINGS, CURRENT MANUFACTURING CONTROLS ARE CONSIDERED ADEQUATE AS TO DETECT AND SEGREGATE ANY NONCONFORMING UNIT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS A MANUFACTURING RELATED ISSUE. . 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." (B(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S PENIS TURNED BLUE AND BEGAN TO SWELL SEVERAL MINUTES AFTER APPLICATION. THE PATIENT EXPERIENCED PAIN BUT DID NOT RECEIVE ANY MEDICAL ATTENTION.

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.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S PENIS TURNED BLUE AND BEGAN TO SWELL SEVERAL MINUTES AFTER APPLICATION. THE PATIENT EXPERIENCED PAIN BUT DID NOT RECEIVE ANY MEDICAL ATTENTION.