BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACIFIER

    MDR report key: 6740032 · Received July 23, 2017

    Report

    Report Number
    MW5071213
    Event Type
    Malfunction
    Date Received
    July 23, 2017
    Date of Event
    July 23, 2017
    Report Date
    July 23, 2017
    Manufacturer
    MAM
    Product Code
    FNN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MONTH NEWBORN SUCKING ON PACIFIER WHEN FATHER NOTICED THE PACIFIER LOOKED FUNNY. TOOK PACIFIER AWAY FROM INFANT AND NOTICED PLASTIC NIPPLE DETACHED FROM PLASTIC POSING A HIGH CHOKING RISK. DATES OF USE: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515518 PACIFIER NIPPLE, LAMBS, FEEDING FNN MAM

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO