FDA Adverse Event
Injury
Summary report: N
BOUNDER
MDR report key: 484572
·
Received September 18, 2003
Report
- Report Number
- 2027797-2003-00002
- Event Type
- Injury
- Date Received
- September 18, 2003
- Date of Event
- September 7, 2003
- Report Date
- September 10, 2003
- Manufacturer
- 21ST CENTURY SCIENTIFIC, INC.
- Product Code
- ITI
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER WAS DRIVING THE CHAIR OUTSIDE AND BROKE THE FORK SPRING BOLT. USER FELL OUT OF THE CHAIR AND SPRAINED/BROKE THEIR LEG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOUNDER | POWER WHEELCHAIR | ITI | 21ST CENTURY SCIENTIFIC, INC. | BIG BOUNDER | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |