FDA Adverse Event
Death
Summary report: N
HOVEROUND CORPORATION
MDR report key: 3093845
·
Received April 26, 2013
Report
- Report Number
- 1056601-2013-00010
- Event Type
- Death
- Date Received
- April 26, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 4, 2013
- Manufacturer
- HOVEROUND CORP.
- Product Code
- INI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OPERATOR ERROR: NO MALFUNCTION OF THE POWER WHEELCHAIR SUSPECTED. THE END USER WAS STRUCK BY A TRUCK WHILE SITTING IN THE POWER WHEELCHAIR. HOVEROUND OWNER'S MANUAL WARNS END USERS "TO AVOID SERIOUS INJURY OR DEATH FROM BEING STRUCK BY A MOTOR VEHICLE, WHEN DRIVING YOUR POWER WHEELCHAIR NEAR TRAFFIC, CROSS ROADS AT LOCATIONS WHERE YOU ARE MOST VISIBLE TO MOTOR TRAFFIC."
Description of Event or Problem · 1
(B)(6) REPORTS END USER WAS SITTING IN POWER WHEELCHAIR AT A STREET CORNER AND WAS STRUCK BY A TRUCK MAKING A RIGHT-HAND TURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181607 | HOVEROUND CORPORATION | MOTORIZED WHEELCHAIR | INI | HOVEROUND CORP. | FWD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Death |