TACTRA
Report
- Report Number
- 2124215-2024-77008
- Event Type
- Injury
- Date Received
- December 6, 2024
- Date of Event
- November 15, 2024
- Report Date
- January 2, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAE
- UDI-DI
- 08714729979357
- PMA / PMN Number
- K183619
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD A TITAN IMPLANTED, THE IMPLANT GOT INFECTED, AND THE PHYSICIAN EXPLANTED THE TITAN AND IMPLANTED A TACTRA MALLEABLE PROSTHESIS. ONE YEAR LATER, A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE TACTRA WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO PATIENT'S PREFERENCE. NO DEVICE MALFUNCTIONS OR PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD A TITAN IMPLANTED, THE IMPLANT GOT INFECTED, AND THE PHYSICIAN EXPLANTED THE TITAN AND IMPLANTED A TACTRA MALLEABLE PROSTHESIS. ONE YEAR LATER, A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE TACTRA WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO PATIENT'S PREFERENCE. NO DEVICE MALFUNCTIONS OR PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2094246 | TACTRA | PROSTHESIS PENILE | FAE | BOSTON SCIENTIFIC CORPORATION | 720081-01 | 0025219228 | 08714729979357 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Hospitalization| R |