BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE WALKER PLATFORM ATTACHMENT

    MDR report key: 23647631 · Received November 25, 2025

    Report

    Report Number
    2438477-2025-00065
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    May 17, 2025
    Report Date
    November 25, 2025
    Manufacturer
    COM-DA HEALTHCARE CO. LTD
    Product Code
    ITJ
    UDI-DI
    00822383109091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WALKER BY A LETTER FROM AN ATTORNEY, ALLEGING THE END USER WAS USING THE DEVICE WHEN THE CRUTCH ATTACHMENT CAME OFF CAUSING THE END USER TO FALL AND REINJURE THEMSELVES. DUE TO THE FALL, THE END USER REQUIRED TO HAVE A REVISION HIP SURGERY. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE DEVICE. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948692 DRIVE DEVILBISS HEALTHCARE WALKER PLATFORM ATTACHMENT WALKER, MECHANICAL ITJ COM-DA HEALTHCARE CO. LTD 10105-1 00822383109091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention