TOROSA SALINE-FILLED TESTICULAR PROSTHESIS
Report
- Report Number
- 2125050-2024-01485
- Event Type
- Injury
- Date Received
- September 20, 2024
- Date of Event
- August 27, 2024
- Report Date
- October 9, 2024
- Manufacturer
- COLOPLAST A/S
- Product Code
- FAF
- UDI-DI
- 05708932470858
- PMA / PMN Number
- P020003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
CORRECTION: BASED ON THE ADDITIONAL INFORMATION THAT THERE WAS NO DEVICE MALFUNCTION, AND THE ADDITIONAL SURGICAL INTERVENTION WAS DUE TO PATIENT PREFERENCE ONLY- ANNEX A010103 AND F1905 WERE REMOVED.
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO PATIENT PREFERENCE AND IMPLANT SIZE.
ACCORDING TO ADDITIONAL INFORMATION, THE ORIGINAL IMPLANT WAS FILLED TO THE PHYSICIAN'S SPECIFICATIONS. THE REVISION WAS PROMPTED BY THE PATIENT WHO WANTED TO MAXIMIZE THE FILL VOLUME ONLY [PATIENT PREFERENCE]. THERE WAS NO REPORTED ISSUE WITH THE IMPLANT AND THE NEW IMPLANT FITTED WAS THE SAME SIZE WITH MAXIMUM FILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1482918 | TOROSA SALINE-FILLED TESTICULAR PROSTHESIS | PROSTHESIS, TESTICULAR | FAF | COLOPLAST A/S | 9391647_5206502400 | 05708932470858 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Required Intervention |