MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number MPV5

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 05/17/2020

Event Type  Injury  

Manufacturer Narrative

The end user's medical condition deteriorated and the end user was no longer able to safely control the power wheelchair in confined spaces as a result of the change in health condition.Hoveround's owner's manual warns "stop using your power wheelchair immediately, and call for assistance if: your condition changes in any way that prevents your from operating your power wheelchair safely.".

Event Description

The end user states while operating the power out of the bathroom, the end user got caught between a piece of furniture and the doorjamb.

• 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: 10404958
• MDR Text Key: 202873413
• Report Number: 1056601-2020-00016
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(11)190924
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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: 11 MO
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2019
• 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: 86 YR
• Patient Weight: 73