BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAC SLOW FLOW NIPPLE AND RING

    MDR report key: 8543519 · Received April 24, 2019

    Report

    Report Number
    8543519
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 5, 2019
    Report Date
    April 9, 2019
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    FNN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MOTHER FED BABY WITH BRAND NEW, SIMILAC, SLOW FLOW NIPPLE. MOTHER NOTICED BABY STRUGGLING WITH FEED. MOTHER NOTED VERY LARGE, OFF CENTER HOLE IN NIPPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337369 SIMILAC SLOW FLOW NIPPLE AND RING FNN ABBOTT NUTRITION 95194SG00

    Patients

    Seq Age Sex Outcome Treatment
    1