BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT HEEL WARMER W/TAPE 4X4

    MDR report key: 1933444 · Received December 20, 2010

    Report

    Report Number
    1423537-2010-00063
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR FOR LOT V0J012 WAS INVESTIGATED. NO ISSUES WERE DOCUMENTED DURING MANUFACTURE. NO PRODUCT SAMPLE WAS PROVIDED. THEREFORE, IT CANNOT BE DETERMINED IF THERE WAS A FAILURE DUE TO IMPROPER TEMPERATURE OF THE THERMAL PACK. MOBERLY'S QUALITY SYSTEMS MANDATE SUITABLE IN-PROCESS CONTROLS TO MEASURE TEMPERATURE INTEGRITY OF REPRESENTATIVE SAMPLES. SAMPLES ARE TESTED AT PREDETERMINED LOCATIONS TO BEST GAUGE TEMPERATURE INTEGRITY. ALL LOTS RELEASED BY THE QUALITY UNIT MEET PREDETERMINED RELEASE CRITERIA.

    Description of Event or Problem · 1

    CHILD CAME IN FOR BLOOD TESTING ON FRIDAY 11/19. THE WARMER WAS PLACED ON CHILDS FINGER TO DO THE FINGER STICK. THE MOTHER SAID THE CHILDS FINGER STAYED PRETTY RED AND THE NEXT MORNING SHE HAD SEVERAL TINY BLISTERS WHERE THE WARMER BURNT THE CHILD. THE MOTHER STATED SHE HAS TAKEN PICTURES AND DOCUMENTED THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT HEEL WARMER W/TAPE 4X4 INFANT HEEL WARMER W/TAPE 4X4 MPO CARDINAL HEALTH 11460-010T V0J012

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other