MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number	MPV5
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Headache (1880); Intracranial Hemorrhage (1891); Concussion (2192)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The client states he hit his head when he fell from the power wheelchair which resulted in a brain bleed and a stroke.The client states he was hospitalized for this incident for over a week.Due to the client's reported injuries, hoveround is reporting this incident.
Event or Problem Description
Client states a few guys on 4-wheeler's were riding on the walk path and he went off of it to get out of the way and pwc fell over.Client states the pwc rolled over a couple of times, sliding off of the levy.Client states he fell out of pwc just before it stopped from sliding over the levy.Client states he was able to get his cell phone out and call 911.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 6015 31st street east; suite 201; bradenton FL 34203
• Manufacturer (Section G): HOVEROUND CORPORATION; 2318 whitfield industrial way; sarasota FL 34243
• Manufacturer Contact: elizabeth cole ; 6015 31st street east; suite 201; bradenton, FL 34203 ; 8007716565
• MDR Report Key: 22883401
• Report Number: 1056601-2025-00004
• Device Sequence Number: 15863240
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(11)210601
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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: MPV5
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Life Threatening; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Hispanic