BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 2770018 · Received September 25, 2012

    Report

    Report Number
    2770018
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    August 10, 2012
    Report Date
    September 20, 2012
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NEW ON-TRIAL WARMING MATTRESS WAS USED FOR THIS CASE BY THE PERFUSIONIST. THE VENDER REP FROM KIMBERLY-CLARK WAS IN THE OR AND DEMONSTRATED THE PRODUCT TO THE SURGICAL TEAM WHEN POSITIONING THE PATIENT FOR THE SURGERY. DURING THE POST OPERATION SKIN ASSESSMENT, THERE WERE SEVERAL RED COLORED DEEP SKIN INDENTATIONS FOUND UNDER BILATERAL AXILLA, ALONG FLANK WHERE THE EDGES AND TAPES OF THE WARMING MATTRESS WERE IN CONTACT WITH THE PATIENT'S SKIN. ONE AREA OF SKIN BREAKDOWN, ABOUT 1 INCH X 1/4 INCH SIZED, WAS ALSO FOUND ON LEFT UPPER BACK CLOSE TO LEFT AXILLA WHERE THE WARMING MATTRESS WAS IN CONTACT WITH THE PATIENT'S SKIN. TWO MDS, OR CHARGE NURSE, TWO RNS WERE ALL PRESENT FOR ASSESSING PATIENT. PATIENT WILL BE FOLLOW UP IN ICU PER MD, AND REFERRING MD WILL BE NOTIFIED PER MD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PATIENT WARMING PAD, GEL DWJ KIMBERLY-CLARK CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR