FDA Adverse Event
Injury
Summary report: N
1020279-2013-00336
MDR report key: 3191388
·
Received June 26, 2013
Report
- Report Number
- 1020279-2013-00336
- Event Type
- Injury
- Date Received
- June 26, 2013
- Date of Event
- January 24, 2013
- Report Date
- June 19, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289946 | JWH | SMITH & NEPHEW, INC. | 054437 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | 21193/0510.13.5697| 0214022/044376| 0214602/054479 |