BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP

Description of Event or Problem

IT WAS REPORTED BY THE PT THAT THE PENILE CLAMP BECAME STUCK TO HIS PENIS. THE PT SOUGHT MEDICAL ATTENTION FROM HIS UROLOGIST AND THE CLAMP WAS REMOVED. THE UROLOGIST WAS CONTACTED BY BARD ON (B)(6)2010. THE UROLOGIST STATED THAT THE PENILE SKIN WAS CAUGHT IN THE CLAMP WIRE. THE DOCTOR INDICATED THAT THE PT DID NOT SEEK IMMEDIATE MEDICAL ATTENTION TO REMOVE THE CLAMP. HE KEPT THE CLAMP ON OVERNIGHT AND RECEIVED MEDICAL ATTENTION THE NEXT DAY. THIS RESULTED IN SWELLING, URINE RETENTION AND SUBSEQUENTLY, INFECTION. THE DOCTOR WAS ABLE TO REMOVE THE CLAMP AND A FOLEY CATHETER WAS PLACED TO ASSIST WITH URINE DRAINAGE. THE INFECTION BECAME SEPTIC SO, THE PT WAS TREATED WITH 14 DAYS OF I.V. ANTIBIOTICS. THE PT WAS IN INTENSIVE CARE FOR 2-3 DAYS AND IN THE HOSPITAL FOR A TOTAL OF 6 DAYS. THE PT IS CURRENTLY ABLE TO URINATE WITHOUT THE USE OF A FOLEY CATHETER.

Additional Manufacturer Narrative

TWO CUNNINGHAM CLAMPS WERE RECEIVED WITH ONE UNIT CARTON FOR EVAL. THIS PRODUCT IS AVAILABLE BY PRESCRIPTION ONLY AND IS SOLD AS ONE CLAMP PER UNIT BOX; THEREFORE, IT IS UNK WHICH CLAMP WAS MFG UNDER THE LOT NUMBER LOCATED ON THE UNIT BOX. THIS ALSO MAKES IT UNCLEAR THE QUANTITY OF PRODUCTS THAT WERE PRESCRIBED AND USED BY THE PT. COMPLETION OF THE DEVICE HISTORY RECORD REVIEW AND EVAL OF THE RETURNED SAMPLES SHOWED THAT THE PRODUCTS DID NOT CONTAIN ANY MFG-RELATED DEFECTS AND THE REPORTED EVENT WAS MOST LIKELY CAUSED BY MISUSE OF THE DEVICE BY THE PT. ONE OF THE RETURNED CLAMPS CONTAINED BLOOD STAINS ON THE METAL LOCK AND ON THE PAD AND IS POSSIBLY THE CLAMP THAT IS ASSOCIATED WITH THE REPORTED INCIDENT. THE STAIN ON THE FOAM PAD AND THE INDENTATION OF THE FOAM WAS NOT CENTERED ON THE CLAMP, BUT WAS LOCATED BETWEEN THE CENTER OF THE PAD AND THE METAL LOCK SUGGESTING THAT THE CLAMP WAS WORN OFF-CENTER TOWARDS THE METAL LOCK. BOTH CLAMPS WERE FUNCTIONALLY TESTED AND PERFORMED AS INTENDED. THE PT DID NOT REMOVE THE CLAMP AT THE TIME OF OCCURRENCE AND DID NOT SEEK MEDICAL ATTENTION UNTIL THE FOLLOWING DAY, WHICH LED TO THE INABILITY TO URINATE AND SUBSEQUENTLY, INFECTION. THE REPORTED INFECTION COULD HAVE BEEN AVOIDED IF THE CLAMP HAD BEEN REMOVED AT THE TIME OF IMPROPER PLACEMENT OF THE PRODUCT. A REVIEW OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING FOR EASY ADJUSTMENT TO GIVE PROPER FIT AND COMFORT: "A VERY LIGHT PRESSURE ON THE URETHRAL CANAL ON THE UNDERSIDE OF THE PENIS WILL PREVENT ANY LEAKAGE. THE NECESSARY PRESSURE IS ACHIEVED BY THE HUMP IN THE UNDER PART OF THE CUNNINGHAM CLAMP. FOR PROPER FIT AND COMFORT, THE UPPER PART OF THE CLAMP CAN BE EASILY SHAPED BY THE FINGERS. 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. BE SURE THAT THE CLAMP IS NOT SET SO TIGHT THAT IT WILL INTERFERE WITH THE BLOOD CIRCULATION." (B)(4).