BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAC INFANT NIPPLE AND RING

    MDR report key: 144738 · Received December 31, 1997

    Report

    Report Number
    144738
    Event Type
    Malfunction
    Date Received
    December 31, 1997
    Date of Event
    December 3, 1997
    Report Date
    December 15, 1997
    Manufacturer
    ROSS PRODUCTS DIVISION ABBOTT LABORATORIES
    Product Code
    FNN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING BOTTLE FEEDING, AFTER INFANT SUCKED ON NIPPLE SEVERAL TIMES, NOTED EXPRESSED BREAST MILK RUNNING DOWN CHIN. WHEN WITHDREW NIPPLE, FROM INFANT'S MOUTH, NOTED TOP OF NIPPLE WAS MISSING. UNABLE TO LOCATE NIPPLE. DEVICE IS NONRADIOPAQUE; THEREFORE, FACILITY IS UNABLE TO DETERMINE IF THE INFANT SWALLOWED THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMILAC INFANT NIPPLE AND RING NIPPLE FNN ROSS PRODUCTS DIVISION ABBOTT LABORATORIES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DAY Other