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	Bruise/Contusion (1754); Bone Fracture(s) (1870)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Client states she was in her bedroom and the pwc lunged forward causing her to run into the wall.Client states as she was in the kitchen trying to go to the door to get a package, client states pwc veered in to the wall where her right toes went under footplate and was caught between the pwc and footplate.Client states her brother came to help her and moved her back from the wall, he unlatched seat belt to help her up.Client states as she went to pivot (client's left leg has been amputated) she fell to the ground.
Additional Manufacturer Narrative
The client states she has a broken ankle and a couple of broken fingers.The client was not admitted to the hospital but due to the fractured ankle and the client being an amputee, hoveround feels this should be reported.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 6015 31st street, ste 201; bradenton FL 34203
• Manufacturer (Section G): HOVEROUND CORPORATION; 2318 whitfield industrial way; sarasota FL 34243
• Manufacturer Contact: elizabeth cole ; 6015 31st streeet east, ste 201; bradenton, FL 34203 ; 8007716565
• MDR Report Key: 22883237
• Report Number: 1056601-2025-00003
• Device Sequence Number: 15854224
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(11)240701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/08/2025

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: 03/10/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic