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