FDA Adverse Event
Injury
Summary report: N
HOVEROUND CORPORATION
MDR report key: 2042100
·
Received March 30, 2011
Report
- Report Number
- 1056601-2011-00006
- Event Type
- Injury
- Date Received
- March 30, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 28, 2011
- Manufacturer
- HOVERROUND CORP
- Product Code
- INI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS BEING RETURNED TO THE MANUFACTURER. AN ASSESSMENT SUMMARY WILL BE FORTH COMING UPON COMPLETION OF THE MANUFACTURER'S EVALUATION.
Description of Event or Problem · 1
END USER ALLEGES WHILE OPERATING THE POWER WHEELCHAIR IN THE ROADWAY HE WAS STRUCK BY A MOTOR VEHICLE. ALLEGEDLY, AS A RESULT OF THE INCIDENT THE END USER WAS HOSPITALIZED. END USER REPORTED NOT WEARING A SEAT BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOVEROUND CORPORATION | MOTORIZED WHEELCHAIR | INI | HOVERROUND CORP | TEK FWD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization |