FDA Adverse Event
Injury
Summary report: N
RASCAL
MDR report key: 1701628
·
Received May 19, 2010
Report
- Report Number
- 2246975-2010-00001
- Event Type
- Injury
- Date Received
- May 19, 2010
- Date of Event
- April 28, 2010
- Report Date
- May 13, 2010
- Manufacturer
- ELECTRIC MOBILITY CORP.
- Product Code
- INI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CUSTOMER RODE SCOOTER THROUGH A WASHED OUT GULLY IN BACKYARD. BROKE LEG IN 5 PLACES AND HAD A STEEL ROD INSERTED. REQUIRED HOSP STAY FOR INJURIES. USER ERROR - NO MALFUNCTION OF UNIT. INSTRUCTED CUSTOMER ON PROPER USE OF UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RASCAL | VEHICLE, 3 WHEELED, MOTORIZED | INI | ELECTRIC MOBILITY CORP. | 300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization |