InjuryFAF
TOROSA
Received May 12, 2014 · Event occurred Apr 8, 2014
Report 2125050-2014-00368 · MDR key 3899181
Device
Generic name
Saline Filled Testicular Prosthesis, Product Code: Faf
Manufacturer
Coloplast A/sModel number
5206502400Catalog number
5206502400
Lot number
3032156
Product problems
- Deflation Problem
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.
Description of Event or Problem
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH TOROSA SALINE TESTICULAR (LARGE). LATER THE PATIENT EXPERIENCED AN EXPLANT OF THE DEVICE DUE TO DEVICE DEFLATION.