InjuryFAF
TOROSA
Received Dec 6, 2011
Report 2125050-2011-00015 · MDR key 2360283
Device
Generic name
Saline Filled Testicular Prosthesis
Manufacturer
Coloplast A/sModel number
5206501400Catalog number
5206501400
Lot number
UNKNOWN
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Pain
Narrative
Additional Manufacturer Narrative
DEVICE REMAINS IMPLANTED; THEREFORE NO DEVICE EVALUATION WAS PERFORMED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST CANNOT CONFIRM THE COMPLAINT OR THE CAUSE OF THE OCCURRENCE. DEVICE STILL IMPLANTED.
Description of Event or Problem
TESTICULAR/SCROTAL PAIN, IMPLANT TOO HARD. DEVICE REMAINS IMPLANTED.