InjuryFAF
TOROSA SALINE-FILLED TESTICULAR PROSTHESIS
Received Jun 10, 2024 · Event occurred May 13, 2024
Report 2125050-2024-00866 · MDR key 19497717
Device
Generic name
Prosthesis, Testicular
Manufacturer
Coloplast A/sCatalog number
450-1325
Lot number
8458956_5206102400
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
36 YR · Male
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE TOROSA WAS REMOVED DUE TO INFECTION.
Additional Manufacturer Narrative
THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED IN VEEVA TO BE ASSOCIATED.