FDA Adverse Event
Summary report: N
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
MDR report key: 2996078
·
Received March 10, 2013
Report
- Report Number
- 1531186-2013-00956
- Date Received
- March 10, 2013
- Report Date
- February 12, 2013
- Manufacturer
- CT MEDICAL, INC.
- Product Code
- INI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE GUIDE BRACKET IS BROKEN CAUSING THE CHAIR TO SPIN AROUND AND COULD CAUSE THE USER TO FALL OFF THE SCOOTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100904 | MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT | 890.3800 | INI | CT MEDICAL, INC. | L-4B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |