MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number TEK FWD

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Injury (2348)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

The end user reported while operating the power wheelchair from the sidewalk onto a steep concrete ramp, the end user fell.The end user was not wearing the seat belt.Hoveround's owner's manual warns "to reduce the chance of serious injury or death loss of control or falling from the power wheelchair, drive in proper environments" and avoid ramps and slopes that are too steep, such as those that exceed 5 degrees." and "[t]o avoid serious injury or death: [a]ways use the seat belt.".

Event Description

While operating the power wheelchair on sidewalk, the end user turned left up a concrete ramp 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: debra silvers ; 2151 whitfield industrial way; sarasota, FL 34243-4047 ; 9418002436
• MDR Report Key: 9536270
• MDR Text Key: 182628353
• Report Number: 1056601-2019-00036
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TEK FWD
• Was Device Available for Evaluation?: No
• Device Age: 4 YR
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• 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: 81 YR
• Patient Weight: 129