BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGULAR SIMILAC NIPPLE

    MDR report key: 3636690 · Received February 11, 2014

    Report

    Report Number
    MW5034548
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 10, 2014
    Product Code
    FNN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFANT BOTTLE FEEDING WITH REGULAR (B)(6) NIPPLE. THE FEEDING WAS NOT FLOWING OUT AND NO BUBBLES NOTED IN BOTTLE; NIPPLE CHANGED AND CHECKED, AND FEEDING DID FLOW OUT MANUALLY. AFTER 10 MINUTES, THE FEEDING STOPPED COMING OUT AND NO BUBBLES NOTED IN BOTTLE. NIPPLE CHANGED AGAIN WITH A NIPPLE FROM DIFFERENT BATCH NUMBER; AND MILK ABLE TO FLOW OUT, BUBBLES NOTED IN BOTTLE, AND INFANT FINISHED FEEDING IN LESS THAN 10 MINUTES. OTHER NIPPLES CHECKED MANUALLY FROM SAME BATCH, AND SAME THING HAPPENED; THE LIQUID WOULD START TO FLOW BUT THEN STOP. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91243 REGULAR SIMILAC NIPPLE REGULAR SIMILAC NIPPLE FNN 34162SG

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO