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	08/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No malfunction suspected.He client was not exercising caution while operating his power wheelchair outside on the sidewalk and drove over an uneven part of the sidewalk that caused him to fall.Additionally, the client did not have his seatbelt properly latched.Hoveround's owner's manual warns "to reduce the chance of serious injury or death from tip-over, collision with obstacles, or falling from the power wheelchair, drive in proper environments: avoid uneven or unstable surfaces such as potholes, broken pavement, grass, gravel, sand, wet leaves or cut grass" and "[t]o reduce the chance of serious injury or death from tip-over, collision with obstacles, loss of control, or falling from the power wheelchair, keep yourself properly positioned in the seat: keep your seat belt fastened, and always use the seat belt.".
Event or Problem Description
The end user reported while operating their power wheelchair outside on a sidewalk, the end user hot an uneven patch in the sidewalk and fell.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 2151 whitfield industrial way; sarasota FL 34243 4047
• MDR Report Key: 11101732
• Report Number: 1056601-2020-00032
• Device Sequence Number: 11802962
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(11)20/07/13
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/31/2020

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: 12/30/2020
• Initial Report FDA Received Date: 12/31/2020
• 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; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 98