BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 14023483 · Received April 6, 2022

    Report

    Report Number
    2438477-2022-00025
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 3, 2022
    Report Date
    April 6, 2022
    Manufacturer
    WU'S TECH CO., LTD.
    Product Code
    INI
    UDI-DI
    00822383519098
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, (B)(6) HEALTHCARE WAS NOTIFIED OF TWO INCIDENTS INVOLVING A SCOUT COMPACT POWER SCOOTER. THE END USER CALLED TO REPORT A "5 BEEP CODE" ON THE UNIT'S BATTERY, BUT ALSO REPORTED THAT THE SCOOTER HAS TIPPED OVER TWICE: ONCE 4 YEARS AGO, WHEN THE END USER DROVE OFF A SMALL RAMP, CAUSING HER TO FALL ON HER HIP AND RESULTING IN A PARTIAL HIP REPLACEMENT; AND ONCE 2 YEARS AGO WHEN THE SCOOTER TIPPED AGAIN WHILE DRIVING DOWN A SMALL RAMP, CAUSING HER TO FALL AND BREAK HER HIP. ALTHOUGH THE END USER ADMITTED THAT BOTH PAST INCIDENTS WERE HER FAULT, DRIVE IS INVESTIGATING AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441701 DRIVE MEDICAL POWER, POV, 4 WHEEL INI WU'S TECH CO., LTD. SFSCOUT4 00822383519098

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Hospitalization| R