BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS CHILDRENS MEDICAL VENTURES INFANT HEEL WARMER

    MDR report key: 4664978 · Received March 31, 2015

    Report

    Report Number
    MW5041915
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 23, 2015
    Manufacturer
    PHILIPS
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USED A PHILIPS INFANT HEEL WARMER PRIOR TO HEEL STICK. WHEN WE REMOVED IT TO DO THE PKU, IT HAD EXPLODED AND THE INSIDE CONTENTS WERE ALL OVER THE BABY'S FOOT. IT DID NOT BURN THE FOOT. SECOND TIME IN THE PAST 2 DAYS THIS HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212752 PHILIPS CHILDRENS MEDICAL VENTURES INFANT HEEL WARMER PHILIPS CHILDRENS MEDICAL VENTURES INFANT HEEL WARMER MPO PHILIPS NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA