FDA Adverse Event
Injury
Summary report: N
HOVEROUND CORPORATION
MDR report key: 1882494
·
Received October 20, 2010
Report
- Report Number
- 1056601-2010-00025
- Event Type
- Injury
- Date Received
- October 20, 2010
- Date of Event
- September 20, 2010
- Report Date
- October 18, 2010
- Manufacturer
- HOVEROUND CORPORATION
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. ACCORDING TO THE END USER, THE BUS DRIVER DID NOT PROPERLY LOWER THE BUS AND THE RAMP WAS TOO STEEP. THE MOTORIZED WHEELCHAIR PERFORMED AS INTENDED DURING EVALUATION IN THE FIELD. END USER REPORTED THAT HE WAS NOT WEARING THE SEAT BELT. THE OWNER'S MANUAL WARNS, "ALWAYS USE THE SEAT BELT".
Description of Event or Problem · 1
END USER ALLEGES WHILE EXITING A PUBLIC TRANSPORT BUS HE FELL OUT OF THE MOTORIZED WHEELCHAIR MIDWAY DOWN THE EXIT RAMP. ALLEGEDLY, AS A RESULT OF THE INCIDENT THE END USER WAS HOSPITALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOVEROUND CORPORATION | MOTORIZED WHEELCHAIR | ITI | HOVEROUND CORPORATION | XHD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization |