BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR SHIELDS

    MDR report key: 464285 · Received May 20, 2003

    Report

    Report Number
    464285
    Event Type
    Other
    Date Received
    May 20, 2003
    Date of Event
    May 12, 2003
    Manufacturer
    AIR SHIELDS / NARCO
    Product Code
    FMT
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REC'D 1-2 DEGREE BURN TO RIGHT SIDE ABOVE UMBILICUS AREA. THE BURN SITE IS APPROX 1 1/2 - 2" LONG. PT WAS UNDER THE RADIANT WARMER AFTER BATH FOR APPROX 40 MINS AND NURSE REMOVED THE THERMISTOR PROBE COVER TO TRANSFER PT. THE NURSE NOTICED THE RED AREA AND SKIN TEAR ON ABDOMEN PER NURSE'S DOCUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELDS INFANT WARMER FMT AIR SHIELDS / NARCO PM78-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other