MAUDE Adverse Event Report: HOVEROUND HOVEROUND; MOTORIZED WHEELCHAIR

Model Number	MPV5
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The client states the sores became infected and client needed to be hospitalized for wound care and then follow up with rehab.Due to seriousness of the injury hoveround felt it was best to report.
Event or Problem Description
Client states when she gets in or out of pwc, the footplate falls down and hits the front of her legs below the knee, on the shins.Client states she has large sores and this has made her weak to the point she is unable to transfer, ambulance was called and she was take to hospital.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND; 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: 22883867
• Report Number: 1056601-2025-00005
• Device Sequence Number: 9604529
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(11)200122
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/19/2025

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: 04/16/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2020
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 91 KG