FDA Adverse Event
Injury
Summary report: N
AMIGO
MDR report key: 467885
·
Received June 24, 2003
Report
- Report Number
- 1821729-2003-00004
- Event Type
- Injury
- Date Received
- June 24, 2003
- Date of Event
- July 17, 2002
- Report Date
- July 17, 2002
- Manufacturer
- AMIGO MOBILITY INT'L INC.
- Product Code
- INI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
USER SUFFERED A HEAD INJURY WHEN PT FELL OUT OF THE SCOOTER AFTER THE EMERGENCY BRAKE FAILED AND THE SCOOTER ROLLED BACK DOWN A HILL AND TRIPPED OVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMIGO | MOTORIZED SCOOTER | INI | AMIGO MOBILITY INT'L INC. | 350000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |