FDA Adverse Event
Injury
Summary report: N
HOVEROUND CORPORATION
MDR report key: 2234099
·
Received August 29, 2011
Report
- Report Number
- 1056601-2011-00018
- Event Type
- Injury
- Date Received
- August 29, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 26, 2011
- Manufacturer
- HOVEROUND CORP.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. THE END USER REPORTED OPERATING THE MOTORIZED WHEELCHAIR IN REVERSE ON A GRASSY/UNEVEN SURFACE. THE OWNER'S MANUAL WARNS, "TO REDUCE THE CHANCE OF SERIOUS INJURY OR DEATH FROM TIP-OVER, COLLISION WITH OBSTACLES AND OTHER PEOPLE, LOSS OF CONTROL, OR FALLING FROM THE POWER WHEELCHAIR, DRIVE IN PROPER ENVIRONMENTS: AVOID UNEVEN OR UNSTABLE SURFACE SUCH AS POTHOLES, BROKEN PAVEMENT, GRASS, GRAVEL, SAND, WET LEAVES OR CUT GRASS".
Description of Event or Problem · 1
END USER ALLEGES WHILE OPERATING THE MOTORIZED WHEELCHAIR IN REVERSE ON AN UNEVEN AND GRASSY SURFACE THE UNIT FELL OVER. 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 CORP. | MPV5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization |