FDA Adverse Event
Injury
Summary report: N
BOUNDER
MDR report key: 666228
·
Received January 18, 2006
Report
- Report Number
- 2027797-2006-00001
- Event Type
- Injury
- Date Received
- January 18, 2006
- Manufacturer
- 21ST CENTURY SCIENTIFIC, INC.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER WAS DRIVING CHAIR DOWN ROAD. THE RIGHT FRONT FORK STEM BROKE. CAUSING THE CHAIR TO VEER TO THE RIGHT INTO A ROAD DITCH. THE CHAIR TIPPED OVER, LANDING ON TOP OF THE USER. THE USER WAS BELTED INTO THE CHAIR.
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 | * | Hospitalization |