InjuryFAF
SALINE TESTICULAR-MEDIUM
Received Feb 3, 2003 · Event occurred Dec 16, 2002
Report 2125050-2003-00028 · MDR key 440533
Device
Generic name
Testicular Prosthesis
Manufacturer
Mentor Corp.-minnesota DivisiModel number
450-1327Catalog number
450-1327
Lot number
90464
Product problems
- Collapse
- Explanted
Patient
26 YR
- Surgical procedure
- Hospitalization required
Narrative
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFO THE PROSTHESIS WAS REMOVED DUE TO IT COLLAPSED. THE DEVICE WAS IMPLANTED WITHOUT FILLING WITH SALINE.
Remedial action
- Replace