MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number	MPV5
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Client states as he was riding down the side walk on n knoxville ave, a pick up truck with trailer turned corner and the trailer hit client.Client states he fell over in the pwc, police and ambulance was called.
Additional Manufacturer Narrative
The client was admitted to the hospital for 3 days post incident so hoveround felt it was best to report.

• 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: 22883897
• Report Number: 1056601-2025-00008
• Device Sequence Number: 9604869
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(11)240917
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/12/2025

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: 07/23/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 84 KG