InjuryFAF
TOROSA
Received Jul 18, 2013 · Event occurred Jun 21, 2013
Report 2125050-2013-00076 · MDR key 3233996
Device
Generic name
Saline Filled Testicular Prosthesis
Manufacturer
Coloplast A/sModel number
5206502400Catalog number
5206502400
Lot number
3557262
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
AS REPORTED TO COLOPLAST BUT NOT VERIFIED, A SECOND SET OF IMPLANTS EXHIBITED LEAKAGE WAS REPORTED DURING FILLING. PATIENT WAS SUBSEQUENTLY IMPLANTED ON (B)(6) 2013.
Additional Manufacturer Narrative
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.