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	Fall (1848); Bone Fracture(s) (1870)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No malfunction suspected.The end user was not exercising caution by operating the power wheelchair at the end of the sidewalk and the end user drove the power wheelchair into a dip and fell.Hoveround's owner's manual warns "driving on soft and/or uneven surfaces increases the chances of a collision or fall from the seat due to loss of control or tip-over and can result in serious injury or death.Avoid driving on these surfaces.".
Event or Problem Description
The end user stated while operating their power wheelchair outdoors, the end user drove off over a dip 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: 11556151
• Report Number: 1056601-2021-00002
• Device Sequence Number: 14410341
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(11)191125
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: 01/12/2021
• Initial Report FDA Received Date: 03/23/2021
• 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: 64 YR
• Patient Weight: 128