FDA Adverse Event
Injury
Summary report: N
REFLECTION
MDR report key: 3040451
·
Received April 8, 2013
Report
- Report Number
- 1020279-2013-00199
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- March 22, 2013
- Report Date
- April 4, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143586 | REFLECTION | LINER | JDH | SMITH & NEPHEW, INC. | 04AM05208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization |