FDA Adverse Event Injury Summary report: N

HOVEROUND CORPORATION

MDR report key: 1233886 · Received November 13, 2008

Report

Report Number
1056601-2008-00027
Event Type
Injury
Date Received
November 13, 2008
Date of Event
September 15, 2007
Report Date
November 10, 2008
Manufacturer
HOVEROUND CORP.
Product Code
ITI
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
KY, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. END USER ADVISED THAT SHE MISJUDGED THE DISTANCE OF THE SEATING UPON TRANSFERRING INTO THE MOTORIZED WHEELCHAIR. THE OWNER'S MANUAL WARNS, "THE OPERATION OF THE POWER CHAIR REQUIRES CAUTION AND CONSIDERATION FOR YOUR PERSONAL SAFETY AND THE SAFETY OF OTHERS AROUND YOU".

Description of Event or Problem · 1

END USER ALLEGES WHILE TRANSFERRING INTO THE MOTORIZED WHEELCHAIR, SHE MISJUDGED THE SEATING DISTANCE AND FELL TO THE FLOOR, ALLEGEDLY, FRACTURING HER LEFT LEG.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HOVEROUND CORPORATION MOTORIZED WHEELCHAIR ITI HOVEROUND CORP. MPV4

Patients

Seq Age Sex Outcome Treatment
1 79 YR Hospitalization| R