FDA Adverse Event
Injury
Summary report: N
REFLECTION
MDR report key: 641560
·
Received October 18, 2005
Report
- Report Number
- 1020279-2005-00354
- Event Type
- Injury
- Date Received
- October 18, 2005
- Date of Event
- September 25, 2004
- Report Date
- October 4, 2005
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
- Product Code
- EJK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REFLECTION | CONSTRAINT LINER | EJK | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | UNK | 04EM00536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R |