FDA Adverse Event
Malfunction
Summary report: N
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
MDR report key: 3699601
·
Received March 25, 2014
Report
- Report Number
- 1525712-2014-01370
- Event Type
- Malfunction
- Date Received
- March 25, 2014
- Date of Event
- February 14, 2014
- Report Date
- February 24, 2014
- Manufacturer
- UNKNOWN
- Product Code
- INI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
END USER STATED THAT THE SCOOTER NO LONGER GOES FORWARD BUT ONLY GOES INTO REVERSE. DEALER STATED NO INJURIES NOR ISSUES OF ABANDONMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174632 | MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT | 890.3800 | INI | UNKNOWN | L-4B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |