InjuryFAF
SALINE-FILLED TESTICULAR PROSTHESIS
Received Jan 28, 2009 · Event occurred Dec 12, 2008
Report 2125050-2009-00001 · MDR key 1297574
Device
Generic name
Testicular Prosthesis
Manufacturer
Coloplast Manufacturing Us LlcModel number
5206501000Catalog number
5206501000
Lot number
5717984
Product problems
- Explanted
- Fluid/Blood Leak
- Material Rupture
Patient
Not reported
- Surgical procedure
Narrative
Description of Event or Problem
AS REPORTED TO COLOPLAST, A PHYSICIAN REPORTED LEAKAGE OF A TESTICULAR PROSTHESIS, WHICH REPORTEDLY RUPTURED SPONTANEOUSLY A FEW DAYS AFTER IMPLANT.
Additional Manufacturer Narrative
ONE TESTICULAR DEVICE WAS RECEIVED FOR EVAL. INVESTIGATION RESULTS ARE PENDING. A FOLLOW-UP REPORT WILL BE FILED.