FDA Adverse Event
Injury
Summary report: N
TACTRA MALLEABLE PENILE PROTHESIS
MDR report key: 9298022
·
Received November 8, 2019
Report
- Report Number
- 2183959-2019-67368
- Event Type
- Injury
- Date Received
- November 8, 2019
- Date of Event
- October 18, 2019
- Report Date
- November 8, 2019
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAE
- UDI-DI
- 08714729979340
- PMA / PMN Number
- K183619
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXPLANT DATE: DATE IS BEST ESTIMATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO IMPLANT A NEW TACTRA MALLEABLE PENILE PROSTHESIS (MPP) FOLLOWING EXPLANT OF THEIR PREVIOUS MPP ON AN UNSPECIFIED DATE FOR UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE MPP WAS REMOVED AND REPLACED DUE TO INFECTION; THE DATE OF EXPLANT COULD NOT BE OBTAINED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE EXPLANTED PRODUCT IS NOT EXPECTED FOR RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1092989 | TACTRA MALLEABLE PENILE PROTHESIS | PROSTHESIS PENILE | FAE | BOSTON SCIENTIFIC CORPORATION | 720080-01 | 0024270314 | 08714729979340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |