FDA Adverse Event
Injury
Summary report: N
TRIGEN
MDR report key: 1882596
·
Received October 26, 2010
Report
- Report Number
- 1020279-2010-00300
- Event Type
- Injury
- Date Received
- October 26, 2010
- Date of Event
- September 22, 2010
- Report Date
- October 26, 2010
- 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 THAT SURGERY TIME WAS EXTENDED DUE TO NAIL/GUIDE ROD MIS-MATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIGEN | NAIL | JDS | SMITH-NEPHEW INC. | 10EM14532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4) |