MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number	XHD
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end user's brother reported while operating the power wheelchair at night in a crosswalk, the end user was struck by a motor vehicle.Hoveround's owner's manual warns "to avoid serious injury or death from being struck by a motor vehicle, when driving your power wheelchair near traffic: obey all local pedestrian traffic rules and cross roads at locations where you are most visible to motor traffic.".
Event or Problem Description
The end user was operating the power wheelchair at night in a crosswalk and was struck by a motor vehicle.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 2151 whitfield industrial way; sarasota, fl
• MDR Report Key: 9805395
• Report Number: 1056601-2020-00005
• Device Sequence Number: 3003216
• Product Code: ITI
• UDI-Device Identifier: 00859781000033
• UDI-Public: (01)00859781000033(11)190129
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: XHD
• Was Device Available for Evaluation?: No
• Device Age: 14 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 65 YR
• Patient Weight: 150