FDA Adverse Event
Other
Summary report: N
PRIDE
MDR report key: 498198
·
Received November 24, 2003
Report
- Report Number
- 2530130-2003-00022
- Event Type
- Other
- Date Received
- November 24, 2003
- Date of Event
- September 16, 2003
- Report Date
- November 24, 2003
- Manufacturer
- PRIDE MOBILITY PRODUCTS EXETER, PA
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE END USER ALLEGES THEY WERE DRIVING DOWN A SLANTED PATH WHEN THEY DROVE OFF AND FELL DOWN A TEN FOOT EMBANKMENT. THE END USER SUSTAINED A FRACTURED VERTEBRAE/SPINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIDE | JAZZY | ITI | PRIDE MOBILITY PRODUCTS EXETER, PA | 1122 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| O |