MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number MPV5

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

No malfunction found.The end user was not exercising caution by not maintaining control and driving the power wheelchair off the curb.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: never attempt to drive a power wheelchair off or up onto a curb, stairs higher than 1.5 inches, or an escalator.

Event Description

The end user reports that while operating the power wheelchair on a sidewalk their hand slipped and they drove off the curb and fell.

• Brand Name: HOVEROUND
• Type of Device: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 6015 31st street e; suite 201; bradenton FL 34203 5317
• Manufacturer (Section G): HOVEROUND CORPORATION; 2151 whitfield industrial way; sarasota FL 34243 4047
• Manufacturer Contact: amanda mcfaddin ; 6015 31st street e; suite 201; bradenton, FL 34203-5317 ; 9418002436
• MDR Report Key: 15406556
• MDR Text Key: 299763355
• Report Number: 1056601-2022-00003
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(10)180403(11)5841950
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 98 KG