TOROSA SALINE-FILLED TESTICULAR PROSTHESIS
Received Jun 3, 2025 · Event occurred May 13, 2025
Report 2125050-2025-00923 · MDR key 22136371
Device
Generic name
Prosthesis, Testicular
Manufacturer
Coloplast A/sCatalog number
450-1329
Lot number
9490802_5206502400
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
73 YR · Male
- Unspecified Infection
- Discomfort
- Unspecified Infection
- Discomfort
Narrative
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. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REPLACED DUE TO INFECTION AND PATIENT PREFERENCE AS THE POSITIONING WAS UNCOMFORTABLE.