BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRIER EASYWARM

    MDR report key: 4223494 · Received October 29, 2014

    Report

    Report Number
    3004763499-2014-00017
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MOLNLYCKE HEALTHCARE
    Product Code
    KGO
    PMA / PMN Number
    K132048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(4). RECEIVED NOTIFICATION THAT A PT GOT A SECOND DEGREE BURN ON HIS RIGHT HEEL (5 CM) AFTER WRONG USE OF THE ACTIVE SELF WARMING BLANKET. THE PT WAS ANESTHETIZED FOR HIP REPLACEMENT SURGERY. THE BURN WAS DISCOVERED AFTER SURGERY, DIRECTLY AFTER REMOVAL OF THE PRODUCT. THE INCIDENT DID PROLONG THE PT'S HOSPITAL STAY, BUT IT IS UNK HOW LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692806 BARRIER EASYWARM KGO MOLNLYCKE HEALTHCARE NA 14 B012

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other