TEROSA
Received May 29, 2014 · Event occurred Apr 29, 2014
Report 2125050-2014-00369 · MDR key 3899179
Device
Generic name
Saline Filled Testicular Prosthesis, Product Code: Faf
Manufacturer
Coloplast A/sModel number
5206302400Catalog number
5206302400
Lot number
3698615
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH TEROSA SALINE TESTICULAR (MED). LATER THE PATIENT EXPERIENCED THE DEVICE LOSING FLUID. AN EXPLANT OF THE DEVICE WAS PERFORMED.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE RETURNED DEVICE, COLOPLAST WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. BASED ON THE EVALUATION, THE DEVICE PERFORMED AS INTENDED AND NO LEAKS WERE FOUND. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.