BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"
Received Jul 19, 2017
Report 1018233-2017-03813 · MDR key 6725658
Device
Generic name
Cunninham Clamp
Manufacturer
C.r. Bard, Inc. (covington) -1018233Catalog number
004053
Lot number
BMAVGS02
Product problems
- Disconnection
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THE PADDING DISCONNECTED FROM THE CLAMP; AS A RESULT, THE CLAMP COULD NOT CLOSE PROPERLY.
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 PADDING DISCONNECTED FROM THE CLAMP; AS A RESULT, THE CLAMP COULD NOT CLOSE PROPERLY.