BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEEL SNUGGLER

    MDR report key: 2478759 · Received February 21, 2012

    Report

    Report Number
    2478759
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 21, 2012
    Manufacturer
    PHILIPS/CHILDREN'S MEDICAL VENTURES
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING USE OF HEEL WARMER IN PREP FOR LAB DRAW, A LARGE AREA OF DISCOLORATION TO LATERAL ASPECT LEFT CALF (1.5CM X 1.5CM) WITH SKIN TEAR IN THE CENTER WAS NOTED BY NURSE. UPON INSPECTION OF THE HEEL WARMER IT WAS NOTED TO HAVE A SMALL PUNCTURE CAUSING LIQUID CONTENT OF HEEL WARMER TO LEAK OUT OF CASING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEEL SNUGGLER HEEL WARMER MPO PHILIPS/CHILDREN'S MEDICAL VENTURES 99047 8092014

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DAY NO OTHER THERAPIES| NONE KNOWN