MalfunctionFAF
TEST
Received Dec 20, 2000
Report 2125050-2000-00272 · MDR key 309311
Device
Generic name
Testicular Products
Manufacturer
Mentor Corporation/minnesota DivisionModel number
450-1126Catalog number
NA
Lot number
67032
Product problems
- Leak/Splash
- Device remains implanted
Patient
47 YR
- Unspecified Infection
- Swollen Lymph Nodes
Narrative
Description of Event or Problem
ACCORDING TO THE INFO RECEIVED, THE PT BEGAN EXPERIENCING EPISODES OF LYMPHADENITIS IN THE GROIN AREA ABOUT TWICE A YEAR. PHYSICIAN FEELS THE TESTICULAR IMPLANT MAYBE LEAKING, PROBABLY CAUSING THE INFECTIONS.
Remedial action
- Other