InjuryFAF
SILASTIC TESTICULAR IMPLANT
Received Feb 16, 2001
Report 1816403-2001-00011 · MDR key 316277
Device
Generic name
Testicular Implant
Manufacturer
Dow Corning Corp.Model number
*Catalog number
UNK
Lot number
UNK
Product problems
- Hole In Material
- Device remains implanted
- Rupture, cause unknown
Patient
35 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
TWO IMPLANTS CO RECEIVED ON 12/4/00 FOR IDENTIFICATION PURPOSES ONLY WITH NO COMPLAINTS REPORTED ON EITHER IMPLANT. UPON INVESTIGATION, IT WAS DETERMINED THAT BOTH IMPLANTS ARE DOW CORNING. DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE RIGHT IMPLANT HAD PUNCTURE HOLES AND THE LEFT IMPLANT WAS RUPTURED.