InjuryFAF
SALINE, TESTICULAR, LARGE
Received Nov 29, 2005 · Event occurred Mar 4, 2004
Report 2125050-2005-00470 · MDR key 649038
Device
Generic name
Testicular Products
Manufacturer
Mentor Corporation - Minnesota DivisionModel number
450-1329Catalog number
450-1329
Lot number
90496
Product problems
- Deflation, cause unknown
- Explanted
- Replace
Patient
NO INFO
- Surgical procedure, repeated
- Surgical procedure
- Hospitalization required
Narrative
Description of Event or Problem
ACCORDING TO THE INITIAL INFORMATION ONE DEVICE HAS DEFLATED BUT NO REVISION SURGERY WAS SCHEDULED. ADDITIONAL INFORMATION RECEVED IN 2005 INDICATED THAT A REVISION SURGERY DID OCCUR IN 2004.
Remedial action
- Other