TOROSA
Received Mar 30, 2015 · Event occurred Feb 18, 2015
Report 2125050-2015-00042 · MDR key 4642588
Device
Generic name
Saline Filled Testicular Prothesis
Manufacturer
Coloplast A/sModel number
5206302400Catalog number
450-1327
Lot number
4254879
Product problems
- Deflation Problem
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
AS REPORTED TO COLOPLAST. THOUGH NOT VERIFIED, THE PATIENT WAS IMPLANTED WITH A TOROSA SALINE FILLED TESTICULAR PROSTHESIS. LATER THE PATIENT EXPERIENCED THAT THE PROTHESIS HAD DEFLATED. AN EXPLANT OF THE DEVICE WAS PERFORMED.
Additional Manufacturer Narrative
BECAUSE THE AVAILABLE INFORMATION PROVIDED INDICATED "LEAKING" MAY HAVE CONTRIBUTED TO THE DEVICE NOT WORKING AS INTENDED/DEVICE DEFLATION, AND BECAUSE NO SECONDARY INJECTION SITE WAS NOTED IN THE INJECTION PORT AND NO CRYSTALIZED RESIDUE WAS PRESENT IN THE DEVICE, QA DETERMINED THAT THE DEVICE WAS MOST LIKELY IMPLANTED WITHOUT BEING PROPERLY FILLED WITH SALINE ACCORDING TO THE IFU INSTRUCTIONS.