FDA Adverse Event
Injury
Summary report: N
INVACARE SCOOTERS
MDR report key: 1003020
·
Received February 25, 2008
Report
- Report Number
- 1525712-2008-00014
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- November 20, 2007
- Report Date
- February 22, 2008
- Manufacturer
- DISTRIBUTED PRODUCT
- Product Code
- INI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
CONSUMER REPORTEDLY WAS LEANING OVER WHILE SEATED IN THEIR SCOOTER. USER ALLEGEDLY LOST THEIR BALANCE AND FELL OFF THE SCOOTER. NO MALFUNCTION APPARENT. CURRENT USER GUIDE COVERS THIS AREA.
Description of Event or Problem · 1
THE CONSUMER WAS REACHING OVER TO TURN HER STEREO SYSTEM OFF, WHEN THE SCOOTER ALLEGEDLY TIPPED OVER AND LEFT HANDLE ON THE TILLER JABBED INTO HER LEFT ARM, CAUSING HER TO FALL ONTO THE FLOOR AND THE SCOOTER FELL ON TOP OF HER. THIS ALLEGEDLY RESULTED IN A CUT REQUIRING STITCHES ON HER ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE SCOOTERS | 890.3800 | INI | DISTRIBUTED PRODUCT | L-3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |