BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE

    MDR report key: 18758653 · Received February 22, 2024

    Report

    Report Number
    2438477-2024-00009
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    December 2, 2023
    Report Date
    February 22, 2024
    Manufacturer
    LERADO H.K. LIMITED
    Product Code
    INI
    UDI-DI
    00822383991771
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY THE PROVIDER THAT AN END USER WAS USING A MOTORIZED SCOOTER IN A PARKING LOT WHEN THE DEVICE WENT OVER A "CONCAVE" BUMP AND THE ENTIRE UNIT FELL OVER. THE END USER'S LEG WAS SCRATCHED/CUT. THE WOUNDS BECAME INFECTED AND THE USER WAS ADMITTED TO THE HOSPITAL FOR CELLULITIS. THE DEVICE IS BEING RETURNED FOR EVALUATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641914 DRIVE DEVILBISS HEALTHCARE VEHICLE, MOTORIZED 3-WHEELED INI LERADO H.K. LIMITED SFPRO317FS-21 00822383991771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization