BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT HEEL WARMER

    MDR report key: 1061869 · Received June 17, 2008

    Report

    Report Number
    MW5007340
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 10, 2008
    Manufacturer
    CHILDRENS MEDICAL VENTURES / RESPIRONICS, INC.
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT HEEL WARMER WAS ACTIVATED AND ATTACHED TO INFANT'S RIGHT FOOT IN PREPARATION OF PKU TEST. MOTHER STATED THAT THE HEEL WARMER HAD LEAKED. THE HEEL PACK WAS FOUND ON MOM'S BED AND WAS LEAKING PURPLE SOLUTION NOTED ON BABY'S RIGHT FOOT AND BEDSHEETS. DR WAS CALLED FOR ASSESSMENT AND TREATMENT. SKIN INTACT TO RIGHT FOOT AND NO BLISTERING NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT HEEL WARMER INFANT HEEL WARMER MPO CHILDRENS MEDICAL VENTURES / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA