MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number MPV5

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Injury (2348)

Event Date 07/25/2020

Event Type  Injury  

Manufacturer Narrative

The end user was not using caution by operating the power wheelchair across a street, not in a crosswalk.The end user was pulling a shopping cart behind the power wheelchair and was not wearing the seat belt when the end user was struck by a motor vehicle.Hoveround's owner's manual warns "to avoid serious injury or death from being struck by a motor vehicle, when driving your power wheelchair near traffic: obey all local pedestrian traffic rules and cross roads at locations where you are most visible to motor traffic." 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 Description

The end user was operating their power wheelchair across a street while pulling a shopping cart behind them when the end user was struck by a motor vehicle.

• Brand Name: HOVEROUND
• Type of Device: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 2151 whitfield industrial way; sarasota, fl
• Manufacturer (Section G): HOVEROUND CORPORATION; 2151 whitfield industrial way; sarasota, fl
• Manufacturer Contact: debra silvers ; 2151 whitfield industrial way; sarasota, fl ; 8002436
• MDR Report Key: 10450067
• MDR Text Key: 204354362
• Report Number: 1056601-2020-00022
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: MPV5
• Was Device Available for Evaluation?: No
• Device Age: 4 YR
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 106