BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATEMP/THERMABASIN

    MDR report key: 931035 · Received October 19, 2007

    Report

    Report Number
    3005853119-2007-00001
    Event Type
    Injury
    Date Received
    October 19, 2007
    Report Date
    October 16, 2007
    Manufacturer
    C CHANGE SURGICAL LLC
    Product Code
    LHC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OFF-LABEL USAGE BY USER FACILITY (NEWBORN BATHING). WRITTEN RECOMMENDATION TO BE SENT TO USER FACILITY AGAINST THIS APPLICATION. REPEATED PHONE CALLS AND VOICEMAIL MESSAGES HAVE ELICITED NO RESPONSE. LABELING REVIEW INITIATED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT OF A NEWBORN HAVING SUFFERED A BURN FROM BEING PLACED INTO OUR DEVICE (IN AN OFF-LABEL USE/APPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRATEMP/THERMABASIN FLUID WARMER - INTRA TEMP/THERMABASIN LHC C CHANGE SURGICAL LLC ITK-6000 76104

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other