Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOVEROUND; MOTORIZED WHEELCHAIR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOVEROUND; MOTORIZED WHEELCHAIR Back to Search Results
Model Number MPV5
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Codes Fall (1848); Bone Fracture(s) (1870)
Date of Event 09/21/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No malfunction suspected.The end user was not exercising caution by operating the power wheelchair while crossing a roadway 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 or Problem Description
The end user stated while operating their power wheelchair crossing a street, the end user was struck by a motor vehicle.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HOVEROUND
Common Device Name
MOTORIZED WHEELCHAIR
MDR Report Key12664314
Report Number1056601-2021-00008
Device Sequence Number19192515
Product Code ITI
UDI-Device Identifier00859781000019
UDI-Public(01)00859781000019(21)5848518
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Model NumberMPV5
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/27/2021
Initial Report FDA Received Date10/20/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured02/26/2019
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age59 YR
Patient Weight70
-
-