BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"
Received Apr 12, 2019
Report 1018233-2019-01933 · MDR key 8509362
Device
Generic name
Cunningham Clamp
Manufacturer
C.r. Bard, Inc. (covington) -1018233Catalog number
004053
Lot number
BMCYGS04
Product problems
- Inadequacy of Device Shape and/or Size
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/BD HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.
Description of Event or Problem
IT WAS REPORTED THAT THE CUNNINGHAM CLAMP WAS LARGER THAN 2 INCHES.
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 THE CUNNINGHAM CLAMP WAS LARGER THAN 2 INCHES.