BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 15571527 · Received October 10, 2022

    Report

    Report Number
    2438477-2022-00096
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    June 19, 2022
    Report Date
    October 10, 2022
    Manufacturer
    LERADO H.K. LTD.
    Product Code
    INI
    UDI-DI
    00822383991771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A POWER SCOOTER BY AN END USER'S DAUGHTER, WHO STATED "HER MOTHER WAS USING THE SCOOTER INSIDE THE HOME ON HARDWOOD FLOORS TO GET AROUND THE HOUSE AND THE SCOOTER FELL ON HER." SHE WAS REPORTEDLY TAKEN TO THE HOSPITAL AND DIAGNOSED WITH A BROKEN WRIST AND FRACTURED LEG, AND HAS BEEN IN A REHAB FACILITY SINCE THE INCIDENT. 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
    245797 DRIVE POWER SCOOTER INI LERADO H.K. LTD. SFPRO317FS-21 00822383991771

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| O