INCONTINENCE CLAMP

Additional Manufacturer Narrative

THE REPORTED EVENT IS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED AND FURTHER INVESTIGATION WAS NOT CONCLUSIVE. A SPECIFIC CAUSE CANNOT BE DETERMINED, HOWEVER, A POTENTIAL ROOT CAUSE FOR THIS EVENT COULD BE, "USER NOT FAMILIAR WITH PRODUCT / PATIENT". THE DEVICE WAS USED FOR TREATMENT PURPOSES. IT IS UNKNOWN IF THE DEVICE HAD MET RELEVANT SPECIFICATIONS OR RESULTED IN THE REPORTED EVENT. A DHR REVIEW CANNOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "DIRECTIONS 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." "BE SURE THAT THE CLAMP IS NOT SET SO TIGHT THAT IT WILL INTERFERE WITH THE BLOOD CIRCULATION." H11: SECTION A THROUGH F - 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 LAST WEEKEND WHEN A PATIENT USED THE CUNNINGHAM CLAMP PRODUCT, IT GAVE THEM A LOT OF PRESSURE IN THE URETHRA. WHILE REMOVING, PATIENT CUT THEMSELVES INSIDE THE URETHRA AFTER IT GOT HOOKED IN THERE, IT CAUGHT THE INSIDE OF THEIR URETHRA. THE PATIENT SAID THAT THEY BLEED FOR TWO DAYS AND USED A Q-TIP WITH PETROLEUM JELLY TO HELP STOP THE BLEEDING ON THE SECOND DAY. PATIENT DID CALL THE DOCTOR AND THAT THE DOCTOR WANTED TO SEE THEM, BUT THEY SAID NO BECAUSE THEY HAD AN APT IN (B)(6) 2023. THE PATIENT WAS NO LONGER CLAMPING AT THIS TIME.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT LAST WEEKEND WHEN A PATIENT USED THE CUNNINGHAM CLAMP PRODUCT, IT GAVE THEM A LOT OF PRESSURE IN THE URETHRA. WHILE REMOVING, PATIENT CUT THEMSELVES INSIDE THE URETHRA AFTER IT GOT HOOKED IN THERE, IT CAUGHT THE INSIDE OF THEIR URETHRA. THE PATIENT SAID THAT THEY BLEED FOR TWO DAYS AND USED A Q-TIP WITH PETROLEUM JELLY TO HELP STOP THE BLEEDING ON THE SECOND DAY. PATIENT DID CALL THE DOCTOR AND THAT THE DOCTOR WANTED TO SEE THEM, BUT THEY SAID NO BECAUSE THEY HAD AN APT IN (B)(6) 2023. THE PATIENT WAS NO LONGER CLAMPING AT THIS TIME.