BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"
Received May 10, 2022 · Event occurred Apr 14, 2022
Report 1018233-2022-03564 · MDR key 14347490
Device
Generic name
Cunningham Clamp
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
004053Catalog number
004053
Lot number
UNK
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
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 CUNNINGHAM CLAMP WOULD NOT OPEN AND CAUSED PATIENT INJURY DUE TO BACKED UP URINE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INJURY.
Additional Manufacturer Narrative
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "DEFECTIVE STEEL MATERIAL FOR RATCHET". THE LOT NUMBER WAS 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 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" 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THE CUNNINGHAM CLAMP WOULD NOT OPEN AND CAUSED PATIENT INJURY DUE TO BACKED UP URINE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INJURY.