FDA Adverse Event
Injury
Summary report: N
HOVEROUND CORPORATION
MDR report key: 1063458
·
Received June 19, 2008
Report
- Report Number
- 1056601-2008-00014
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- September 18, 2007
- Report Date
- June 19, 2008
- Manufacturer
- HOVEROUND CORPORATION
- 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 MOTORIZED WHEELCHAIR SUSPECTED. END USER REPORTED BEING STRUCK BY A MOTOR VEHICLE. THE EQUIPMENT IS NOT AVAILABLE FOR EVALUATION BY HOVEROUND.
Description of Event or Problem · 1
END USER ALLEGES WHILE OPERATING THE MOTORIZED WHEELCHAIR IN A CROSSWALK, HE WAS STRUCK BY A MOTOR VEHICLE. ALLEGEDLY, AS A RESULT OF THE INCIDENT, END USER SUSTAINED MULTIPLE FRACTURES AND REQUIRED HOSPITALIZATION AND SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOVEROUND CORPORATION | MOTORIZED WHEELCHAIR | ITI | HOVEROUND CORPORATION | MPV5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R |