TOROSA SALINE-FILLED TESTICULAR PROSTHESIS
Received Aug 27, 2025 · Event occurred Jul 3, 2025
Report 2125050-2025-01368 · MDR key 22907517
Device
Generic name
Prosthesis, Testicular
Manufacturer
Coloplast A/sCatalog number
450-1327
Lot number
9338035_5206302400
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
31 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, TWO TOROSA TESTICULAR DEVICES WERE EXPLANTED FOR AN UNKNOWN REASON. THE ADDITIONAL TOROSA DEVICE IS CAPTURED UNDER A SEPARATE REPORT.
Additional Manufacturer Narrative
TESTICULAR IMPLANT WAS RECEIVED FOR EVALUATION. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE TESTICULAR. THE INFORMATION RECEIVED INDICATED THE DEVICE WAS EXPLANTED DUE TO UNKNOWN REASONS, AND BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCE'S AND CAPAS REVEALED NO TRENDS FOR THIS LOT.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, TWO TOROSA TESTICULAR DEVICES WERE EXPLANTED FOR AN UNKNOWN REASON. THE ADDITIONAL TOROSA DEVICE IS CAPTURED UNDER A SEPARATE REPORT.
Additional Manufacturer Narrative
THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION 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.