InjuryFAF
SALINE TESTICULAR, MEDIUM
Received Feb 3, 2003 · Event occurred Jan 13, 2003
Report 2125050-2003-00027 · MDR key 440619
Device
Generic name
Testicular Products
Manufacturer
Mentor Corp - Minnesota DivisionModel number
450-1327Catalog number
450-1327
Lot number
NA
Product problems
- Deflation, cause unknown
- Explanted
Patient
57 YR
- Surgical procedure
- Hospitalization required
Narrative
Description of Event or Problem
ACCORDING TO THE INFO RECEIVED THE DEVICE WAS REMOVED DUE TO DEFLATION. ADD'L INFO RECEIVED INDICATED THAT INSTRUCTIONS NOT GIVEN FOR FILLING.
Remedial action
- Replace