MalfunctionFHA
BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"
Received Jan 31, 2020
Report 1018233-2020-00673 · MDR key 9652970
Device
Generic name
Cunningham Clamp
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
004053Catalog number
004053
Lot number
UNK
Product problems
- Contamination /Decontamination Problem
Patient
Male
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
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 WAS LABELED AS A MEDIUM; HOWEVER, A LARGE PRODUCT WAS INSIDE OF THE PACKAGE.