FDA Adverse Event
Summary report: N
1020279-2014-00416
MDR report key: 3932688
·
Received July 14, 2014
Report
- Report Number
- 1020279-2014-00416
- Date Received
- July 14, 2014
- Date of Event
- September 4, 2012
- Report Date
- August 9, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED. THE REASON IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409784 | JWH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |