BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHILDREN'S MEDICAL VENTURES HEEL SNUGGLER

    MDR report key: 1405211 · Received June 18, 2009

    Report

    Report Number
    1405211
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    April 17, 2009
    Report Date
    June 18, 2009
    Manufacturer
    RESPIRONICS INC
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    HEEL WARMER PLACED ON INFANT PRIOR TO DRAWING LABS. WHEN REMOVED, PURPLE SOLUTION WAS NOTED ON THE INFANT'S FOOT WITH WHITE POWDERY SUBSTANCE ON THE CALF. CLEANED WITH STERILE SALINE WIPES. FOOT REMAINED REDDENED ON OUTSIDE PORTION OF SOLE OF FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILDREN'S MEDICAL VENTURES HEEL SNUGGLER HEEL WARMER MPO RESPIRONICS INC 99047 *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA