BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOFLECT

    MDR report key: 1553108 · Received December 4, 2009

    Report

    Report Number
    1553108
    Event Type
    Injury
    Date Received
    December 4, 2009
    Date of Event
    November 22, 2009
    Report Date
    December 4, 2009
    Manufacturer
    ENCOMPASS THERAPUTIC SUPPORT SYSTEMS
    Product Code
    KME
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE SCANNED A PATIENT WITH AN MRI WHILE A HYPOTHERMIA BLANKET WITH ALUMINUM ON ONE SIDE. THE BLANKET WAS MRI CONDITIONAL AND IT MAY BE THE REASON OUR PATIENT SUFFERED A THIRD DEGREE BURN. THE PATIENT WILL HAVE TO BE GRAFTED. THE BLANKET IS PAPER/BLUE ON ONE SIDE AND ALUMINUM/SILVER ON THE OTHER. THE SILVER SIDE IS INTENDED TO BE PLACED AWAY FROM THE PATIENT'S SKIN. HOWEVER, THERE IS NOTHING ON THE BLANKET THAT WOULD ALERT A PROVIDER THAT THIS SHOULD NOT COME INTO CONTACT WITH THE PATIENT'S SKIN.

    Description of Event or Problem · 1

    WE SCANNED A PATIENT WITH AN MRI WHILE A HYPOTHERMIA BLANKET WITH ALUMINUM ON ONE SIDE. THE BLANKET WAS MRI CONDITIONAL AND IT MAY BE THE REASON OUR PATIENT SUFFERED A THIRD DEGREE BURN. THE PATIENT WILL HAVE TO BE GRAFTED. THE BLANKET IS PAPER/BLUE ON ONE SIDE AND ALUMINUM/SILVER ON THE OTHER. THE SILVER SIDE IS INTENDED TO BE PLACED AWAY FROM THE PATIENT'S SKIN. HOWEVER, THERE IS NOTHING ON THE BLANKET THAT WOULD ALERT A PROVIDER THAT THIS SHOULD NOT COME INTO CONTACT WITH THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOFLECT BLANKET, PATIENT, MRI KME ENCOMPASS THERAPUTIC SUPPORT SYSTEMS * *
    2 SIGNA HORIZON LX IMAGING, MAGNETIC RESONANCE SYSTEM LNH GE MEDICAL SYSTEMS, LLC SINGA HORIZON LX *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Hospitalization| O| R