BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 16887076 · Received May 8, 2023

    Report

    Report Number
    2438477-2022-00145
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    September 7, 2022
    Report Date
    May 8, 2023
    Manufacturer
    LERADO H.K. LTD.
    Product Code
    INI
    UDI-DI
    00822383991771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A POWER SCOOTER BY AN END USER WHO STATED THAT JUST AFTER HE HAD "ADJUSTED THE SEAT AS IT WAS TOO HIGH," HE WAS BEING TRANSPORTED AND "THE SEAT SLID COMPLETELY OFF THE SCOOTER BODY." IT IS UNCLEAR HOW THE END USER WAS BEING TRANSPORTED. THE END USER REPORTEDLY SUSTAINED INJURIES TO HIS SHOULDER AND AGGRAVATED AN ALREADY BAD HIP AS A RESULT OF THE INCIDENT, AND SOUGHT TREATMENT IN THE EMERGENCY ROOM. DRIVE 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
    726927 DRIVE POWER SCOOTER INI LERADO H.K. LTD. SFPRO317FS-21 00822383991771

    Patients

    Seq Age Sex Outcome Treatment
    1 Male