MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number MPV5

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Vertebral Fracture (4520)

Event Date 07/19/2021

Event Type  Death  

Manufacturer Narrative

No malfunction suspected.According to a report from the (b)(6) police department, the end user was not exercising caution by operating the power wheelchair on a roadway against oncoming traffic and 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.".

Event Description

The police report stated while operating their power wheelchair on a roadway against oncoming traffic, 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 34243 4047
• Manufacturer (Section G): HOVEROUND CORPORATION; 2151 whitfield industrial way; sarasota FL 34243 4047
• Manufacturer Contact: pasquale muia ; 2151 whitfield industrial way; sarasota, FL 34243-4047 ; 9418002512
• MDR Report Key: 12314130
• MDR Text Key: 266245559
• Report Number: 1056601-2021-00006
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• 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): Death
• Patient Age: 49 YR
• Patient Weight: 70