FDA Adverse Event
Injury
Summary report: N
TRIGEN
MDR report key: 3944870
·
Received July 18, 2014
Report
- Report Number
- 1020279-2014-00438
- Event Type
- Injury
- Date Received
- July 18, 2014
- Report Date
- July 16, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421906 | TRIGEN | IMPLANT | JDS | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |