BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFANT HEEL WARMER

    MDR report key: 3533120 · Received October 22, 2013

    Report

    Report Number
    MW5033548
    Event Type
    Other
    Date Received
    October 22, 2013
    Date of Event
    October 16, 2013
    Report Date
    October 21, 2013
    Manufacturer
    ARGYLE
    Product Code
    MPO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PACKAGING OF PRODUCT (ARGYLE INFANT HEEL WARMER) BROKE APART WHILE SQUEEZING TO APPLY ON INFANTS HEEL FOR PKU TEST. THE FLUID IN THE PACK SPILLED ALL OVER THE INFANT AND NURSE PERFORMING THE TEST AS WELL AS SURROUNDING OBJECTS. CHEMICALS GOT ON TO THE INFANTS FACE BUT WAS WIPED OFF IMMEDIATELY, NO BURNING, CHANGE IN SKIN OR APPARENT DISTRESS TO INFANT. DATES OF USE: (B)(6) 2013. REASON FOR USE: INFANT HEEL WARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541260 INFANT HEEL WARMER INFANT HEEL WARMER MPO ARGYLE

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Other