FDA Adverse Event
Injury
Summary report: N
1020279-2013-00235
MDR report key: 3082102
·
Received April 29, 2013
Report
- Report Number
- 1020279-2013-00235
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 24, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185164 | JWH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |