BEUDAMED
    FDA Adverse Event Injury Summary report: N

    READY-HEAT

    MDR report key: 1311186 · Received February 10, 2009

    Report

    Report Number
    MW5009941
    Event Type
    Injury
    Date Received
    February 10, 2009
    Date of Event
    February 1, 2009
    Report Date
    February 10, 2009
    Manufacturer
    TECHTRADE LLC
    Product Code
    DWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    READY-HEAT, HEATED DISPOSABLE MINI BLANKET USED TO PROVIDE WARMTH TO NEWBORN IN THE DELIVERY ROOM. BLANKET WAS PLACED ON MATTRESS THEN COVERED WITH AN INCONTINENCE PAD. THE NEWBORN WAS WRAPPED IN A TOWEL AND PLACED ON TOP OF THE INCONTINENCE PAD. FOR APPROXIMATELY 40 MINUTES THE INFANT WAS PROVIDED CARE ON THIS SURFACE, INCLUDING ASSESSMENT, VIGOROUS "RUBBING" AND "BLOW BY" OXYGEN. THE INFANT SUSTAINED A SECOND DEGREE BURN TO THE RIGHT SIDE OF THE BACK MEASURING 9 CM X 6.5 CM. PATIENT NEEDED ADDITIONAL CARE FOR THE BURN. THE BLISTER DID NOT APPEAR FOR SEVERAL HOURS AND THE DISPOSABLE BLANKET AND BEEN DISCARDED. THE READY-HEAT MINI BLANKET HAS BEEN USED TWICE IN THIS FACILITY ON NEWBORNS. THE FIRST EVENT DID NOT CAUSE AN INJURY. THIS PRODUCT IS SUSPECTED TO HAVE CAUSED THE BURN DUE TO UNEVEN HEAD DISTRIBUTION NOTED WHEN ANOTHER BLANKET FROM THE SAME CASE OF PRODUCT WAS OPENED. BOTH OF THE RADIANT HEAT INFANT WARMERS THE BABY HAD BEEN PLACED UNDER, ONE IN THE DELIVERY ROOM AND THE OTHER IN THE NURSERY, WERE TESTED BY THE HOSPITAL BIOMEDICAL DEPARTMENT AND WERE FOUND TO BE FUNCTIONING WITHIN NORMAL LIMITS. ADDITIONALLY, OTHER INFECTIOUS CAUSES OF BLISTERING WERE RULED OUT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 READY-HEAT READY-HEAT HEATED DISPOSSABLE MINI-BLANKET DWJ TECHTRADE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O HILL-ROM RADIANT WARMER| DRAEGER INFANT WARMER