BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 3092609 · Received March 27, 2013

    Report

    Report Number
    3092609
    Date Received
    March 27, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    DWJ
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH TWO AREAS OF BLANCHING PINK TO LIGHT RED ERYTHEMA, ONE OVER EACH SCAPULA. PATIENT HAD EXTENSIVE CARDIAC SURGERY DONE SEVERAL DAYS PRIOR AND I BELIEVE HAD A KIMBERLY CLARK WARMER ON. COULD BE 1ST DEGREE BURNS. SPOKE WITH HIS NURSE A FEW DAYS LATER AND ONE SIDE HAS "OPENED UP A LITTLE BIT" POSSIBLY MAKING THAT AREA A 2ND DEGREE BURN. WHILE EXAMINING PATIENT AT BEDSIDE, TWO REDDENED AREAS RESEMBLING THERMAL BURNS NOTED ON PATIENT'S BACK AT LEVEL OF THE SHOULDER BLADES BILATERALLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PT HAD EXTENSIVE CARDIAC SURGERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126445 * SYSTEM, THERMAL REGULATING, WARMING PADS DWJ KIMBERLY-CLARK CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR