InjuryFAF
SALINE-FILLED TESTICULAR PROSTHESIS
Received Jun 4, 2008 · Event occurred Apr 16, 2008
Report 2125050-2008-00001 · MDR key 1056478
Device
Generic name
Testicular Prosthesis
Manufacturer
Coloplast Manufacturing Us, LlcModel number
450-1327Catalog number
450-1327
Lot number
5715434
Product problems
- Explanted
- Fluid/Blood Leak
Patient
Not reported
- Surgical procedure
Narrative
Description of Event or Problem
AS REPORTED TO COLOPLAST, THE TESTICULAR LOST FLUID.
Additional Manufacturer Narrative
ONE TESTICULAR DEVICE WAS RECEIVED FOR EVAL. EXAMINATION AND TESTING OF THE RETURNED COMPONENT REVEALED NO FUNCTIONAL ABNORMALITIES. BECAUSE NO FUNCTIONAL ABNORMALITIES WERE OBSERVED, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.
Remedial action
- Other