BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKU INFANT HEEL WARMER

    MDR report key: 6696570 · Received July 7, 2017

    Report

    Report Number
    MW5070849
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    June 3, 2017
    Report Date
    July 5, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEM
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PKU WARMER POPPED AND EXPLODED HOT LIQUID PARTICLES WHEN DEVICE BUTTON WAS PRESSED ON. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473621 PKU INFANT HEEL WARMER INFANT HEEL WARMER MPO PHILIPS MEDICAL SYSTEM 050317

    Patients

    Seq Age Sex Outcome Treatment
    1