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	Bone Fracture(s) (1870)
Date of Event	05/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hoveround is reporting the incident based on the client's statements of her injuries.The client was hospitalized for a period of time after her incident so she was unable to notify hoveround at the time.The client is unaware of where the device was taken after the accident, it is not in her possession.
Event or Problem Description
The client states as she was on her way home and crossing the street to get to the sidewalk, a big truck hit her.The client states she was on the ground, does not remember what side she was hit on and she was going in and out of consciousness.The client states her next memory is waking up in the hospital.

• 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: 22882899
• Report Number: 1056601-2025-00007
• Device Sequence Number: 8861174
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(11)220524
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/17/2025

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White