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