FDA Adverse Event
Malfunction
Summary report: N
RASCAL
MDR report key: 495145
·
Received November 10, 2003
Report
- Report Number
- 2246975-2003-00100
- Event Type
- Malfunction
- Date Received
- November 10, 2003
- Date of Event
- October 11, 2003
- Report Date
- October 13, 2003
- Manufacturer
- ELECTRIC MOBILITY CORP.
- Product Code
- INI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
WHEEL HUB CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RASCAL | VEHICLE, 3-WHEEL MOTORIZED | INI | ELECTRIC MOBILITY CORP. | 245 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |