BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 16820907 · Received April 26, 2023

    Report

    Report Number
    9616873-2023-00002
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 3, 2022
    Report Date
    March 24, 2022
    Manufacturer
    WU'S TECH CO., LTD.
    Product Code
    INI
    UDI-DI
    00822383519098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED ON (B)(6) 2022 REGARDING A SFSCOUT4, A COMPACT POWER SCOOTER THAT IS "GETTING A 5 BEEP CODE". THE END USER HAS CHANGED THE BATTERIES SINCE PURCHASED IN 2017. THE END USER ALSO STATES THAT "THE SCOOTER TIPPED OVER THE FIRST TIME ABOUT 4 YEARS AGO, THE SCOOTER TIPPED OVER A SECOND TIME ABOUT 2 YEARS AGO. THE END USER RECEIVED BROKEN HIPS ON BOTH OCCASIONS DUE TO THIS SCOOTER TIPPING OVER. 1ST INCIDENT: DROVE OFF OF SMALL RAMP, FELL ON HIP AND HAD PARTIAL HIP REPLACEMENT 2ND INCIDENT: SCOOTER TIPPED OVER WHILE DRIVING DOWN SMALL RAMP" CUSTOMER ADMITS THAT THEY ARE AT FAULT. CURRENTLY, THIS DEVICE WILL NOT BE RETURNED FOR EVALUATION. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746693 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