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	Fall (1848)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No malfunction found.The end user was not exercising caution by not maintaining control and driving the power wheelchair off the curb.Hoveround's owner's manual warns "to reduce the chance of serious injury or death from tip-over, collision with obstacles and other people, loss of control, or falling from the power wheelchair, drive in proper environments: never attempt to drive a power wheelchair off or up onto a curb, stairs higher than 1.5 inches, or an escalator.
Event or Problem Description
The end user reports that while operating the power wheelchair on a sidewalk their hand slipped and they drove off the curb and fell.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 6015 31st street e; suite 201; bradenton FL 34203 5317
• Manufacturer (Section G): HOVEROUND CORPORATION; 2151 whitfield industrial way; sarasota FL 34243 4047
• Manufacturer Contact: amanda mcfaddin ; 6015 31st street e; suite 201; bradenton, FL 34203-5317 ; 9418002436
• MDR Report Key: 15406556
• Report Number: 1056601-2022-00003
• Device Sequence Number: 6745091
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(10)180403(11)5841950
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 98 KG