BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 14988041 · Received July 12, 2022

    Report

    Report Number
    2438477-2022-00064
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    March 23, 2022
    Report Date
    July 11, 2022
    Manufacturer
    JHR ELECTRIC TRANSPORTS, LLC
    Product Code
    INI
    UDI-DI
    00822383563510
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE RECEIVED A COMPLAINT INVOLVING A POWER SCOOTER FROM AN END USER, WHO REPORTED THAT THE SCOOTER "CAUSED ME INJURY WHEN THE FRONT WHEEL FELL OFF" WHILE HE WAS RIDING IT AT 10MPH, CAUSING HIM TO BE "THROWN INTO THE PAVEMENT." THE END USER REPORTED SEEKING MEDICAL ATTENTION BUT IS CURRENTLY NOT RESPONDING TO DRIVE'S ATTEMPTS AT CONTACT TO GATHER FURTHER INFORMATION. DRIVE WILL CONTINUE ATTEMPTING TO INVESTIGATE THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT, AND WILL UPDATE THIS FILING IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701905 DRIVE SCOOTER INI JHR ELECTRIC TRANSPORTS, LLC ZOOME3 00822383563510

    Patients

    Seq Age Sex Outcome Treatment
    1 Male