BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS CHILDREN'S MEDICAL VENTURES HEEL SNUGGLER

    MDR report key: 4628139 · Received March 18, 2015

    Report

    Report Number
    MW5041605
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 18, 2015
    Manufacturer
    PHILIPS CHILDREN'S MEDICAL VENTURES
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHILIPS CHILDREN'S MED VENTURES HEEL SNUGGLER WAS APPLIED APPROPRIATELY TO INFANT HEEL. WHEN REMOVING PRODUCT FOR LAB DRAW HEEL SNUGGLER BURST OPEN AND CONTENTS WENT ALL OVER INFANT FOOT. INTERNAL CONTENTS HAVE POTENTIAL TO BE VERY HOT AND CAN CAUSE BURNS. INFANT'S HEEL WIPED CLEAN IMMEDIATELY. NO ADVERSE EFFECT/NO PERMANENT DAMAGE TO HEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185907 PHILIPS CHILDREN'S MEDICAL VENTURES HEEL SNUGGLER HEEL SNUGGLER MPO PHILIPS CHILDREN'S MEDICAL VENTURES HEEL SNUGGLER 99047

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA