FDA Adverse Event
Malfunction
Summary report: N
RASCAL
MDR report key: 380887
·
Received March 8, 2002
Report
- Report Number
- 2246975-2002-00006
- Event Type
- Malfunction
- Date Received
- March 8, 2002
- Date of Event
- February 13, 2002
- Report Date
- February 15, 2002
- Manufacturer
- ELECTRIC MOBILITY CORP
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATED THAT WHILE CROSSING AN INTERSECTION THE UNIT HESITATED MOMENTARILY AND THEN WAS STRUCK BY A MOTOR VEHICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RASCAL | VEHICLE, 4-WHEEL MOTORIZED | ITI | ELECTRIC MOBILITY CORP | 325 | R0200929 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization |