FDA Adverse Event
Injury
Summary report: N
HOVEROUND CORPORATION
MDR report key: 1151400
·
Received September 4, 2008
Report
- Report Number
- 1056601-2008-00022
- Event Type
- Injury
- Date Received
- September 4, 2008
- Date of Event
- July 15, 2008
- Report Date
- September 3, 2008
- Manufacturer
- HOVEROUND CORPORATION
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. THE POLICE REPORT STATES THAT END USER WAS OPERATING THE POWER WHEELCHAIR IN THE ROADWAY, AGAINST TRAFFIC AND DID NOT STOP BEFORE CROSSING THE INTERSECTION. THE OWNER'S MANUAL WARNS, "DO NOT DRIVE YOUR MPV 4 ON THE ROADWAY OR PUBLIC STREETS".
Description of Event or Problem · 1
ACCORDING TO THE POLICE REPORT THE END USER WAS OPERATING THE MOTORIZED WHEELCHAIR IN THE ROADWAY AND WAS STUCK BY A MOTOR VEHICLE WHILE ATTEMPTING TO CROSS THE ROADWAY. ALLEGEDLY, AS A RESULT OF THE INCIDENT, THE END USER REQUIRED HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOVEROUND CORPORATION | MOTORIZED WHEELCHAIR | ITI | HOVEROUND CORPORATION | MPV4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization |