MAUDE Adverse Event Report: HOVEROUND; MOTORIZED WHEELCHAIR

Model Number	MPV5
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No malfunction suspected.The end user was not exercising caution by operating the power wheelchair on a snowy sidewalk.While avoiding a snowbank the end user drove off the curb and fell.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: do not operate the power wheelchair in conditions such as rain, standing water, sleet, slush or snow.".
Event or Problem Description
The end user stated while operating their power wheelchair they went around a snowbank, drove off the curb and fell.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• MDR Report Key: 12664311
• Report Number: 1056601-2021-00009
• Device Sequence Number: 13813022
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(21)5849715
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 10/18/2021

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: 09/28/2021
• Initial Report FDA Received Date: 10/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 91