BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURN SHEET

    MDR report key: 6504871 · Received April 19, 2017

    Report

    Report Number
    1422443-2017-00001
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Date of Event
    March 7, 2017
    Report Date
    April 19, 2017
    Manufacturer
    DUKAL CORPORATION
    Product Code
    FPY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS FALLING APART WHEN APPLIED TO A (B)(6)-OLD BABY FOR SECOND DEGREE BURNS. THE BURN SHEET ADHERED TO THE BABY. WHEN THE BURN SHEET WAS TRIED TO BE REMOVED, THE SKIN CAME WITH IT. THE INFANT HAD TO HAVE THE BURN SHEET SURGICALLY REMOVED FROM HIS SKIN. ATTEMPTS TO OBTAIN THE PROTOCOL USED BY THE FIRE DEPARTMENT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285606 BURN SHEET BURN SHEET FPY DUKAL CORPORATION 650-3001-0100 JT36212

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO