FDA Adverse Event
Injury
Summary report: N
HOVEROUND CORPORATION
MDR report key: 3981192
·
Received July 23, 2014
Report
- Report Number
- 1056601-2014-00013
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- March 20, 2014
- Report Date
- July 22, 2014
- Manufacturer
- HOVEROUND CORP.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION OF THE POWER WHEELCHAIR SUSPECTED. THE END USER WAS STRUCK BY A MOTOR VEHICLE WHILE CROSSING THE STREET IN THE POWER WHEELCHAIR.
Description of Event or Problem · 1
END USER WAS REPORTEDLY CROSSING THE ROADWAY IN A CROSSWALK IN THE POWER WHEELCHAIR WHEN SHE WAS STRUCK AND THEN DRAGGED BY A MOTOR VEHICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432241 | HOVEROUND CORPORATION | MOTORIZED WHEELCHAIR | ITI | HOVEROUND CORP. | HOVEROUND MPV5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization |