BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHILDREN'S MEDICAL VENTURES

    MDR report key: 4755195 · Received May 6, 2015

    Report

    Report Number
    4755195
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 6, 2015
    Manufacturer
    PHILIPS CHILDREN'S MEDICAL VENTURES
    Product Code
    LQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CONCERN FOR POTENTIAL HARM TO INFANT WHEN MEMBRANE ON PACIFIER COMES OUT (SMALL HOLE LOCATED IN MIDDLE OF PACIFIER DISLODGES). POTENTIAL FOR ASPIRATION.======================MANUFACTURER RESPONSE FOR SOOTHIE NEWBORN PACIFIER, CHILDREN'S MEDICAL VENTURES (PER SITE REPORTER).======================CONTACTED REP AND ORDER NUMBER WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296199 CHILDREN'S MEDICAL VENTURES SOOTHIE NEWBORN PACIFIER LQX PHILIPS CHILDREN'S MEDICAL VENTURES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *