BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 16043030 · Received December 23, 2022

    Report

    Report Number
    2438477-2022-00115
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Report Date
    December 23, 2022
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ITJ
    UDI-DI
    00822383119427
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WALKER BY AN END USER, WHO STATED THAT THE LEG FRAME SNAPPED AND RESULTED IN A FALL, WHICH CAUSED SOME BRUISING. THE COMPLAINANT WAS UNABLE TO SPECIFY THE LOCATION OF THE BRUISING. 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
    1739094 DRIVE WALKER ITJ COM-DA HEALTHCARE CO.,LTD 10240-1 00822383119427

    Patients

    Seq Age Sex Outcome Treatment
    1 Male