BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 11072172 · Received December 24, 2020

    Report

    Report Number
    2438477-2018-00094
    Event Type
    Injury
    Date Received
    December 24, 2020
    Date of Event
    September 11, 2018
    Report Date
    December 24, 2020
    Manufacturer
    COM-DA HEALTHCARE
    Product Code
    ITJ
    UDI-DI
    00822383119427
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WALKER. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE SNAPPED WHILE IN USE AND HE FELL HITTING HIS BACK AND HEAD. AN AMBULANCE WAS CALLED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536698 DRIVE WALKER ITJ COM-DA HEALTHCARE 10240-1 00822383119427

    Patients

    Seq Age Sex Outcome Treatment
    1