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 05/01/2019

Event Type  Injury  

Manufacturer Narrative

No malfunction suspected.The end user was not exercising caution by operating the power wheelchair on a sidewalk with broken pavement.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 "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 Description

The end user stated while operating their power wheelchair on a sidewalk the end user drove over broken pavement and fell.

• 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: 11888625
• MDR Text Key: 260248351
• Report Number: 1056601-2021-00004
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• 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; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 118