BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAC INFANT NIPPLE AND RING

    MDR report key: 112950 · Received August 13, 1997

    Report

    Report Number
    MW1011878
    Event Type
    Malfunction
    Date Received
    August 13, 1997
    Date of Event
    July 11, 1997
    Report Date
    August 13, 1997
    Manufacturer
    ROSS PRODUCTS DIVISION ABBOTT LABS
    Product Code
    FNN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DISCHARGED FROM NEONATAL INTENSIVE CARE AND GIVEN FORMULA AND NIPPLES FOR HOME USE. PARENTS DISCOVERED A FOREIGN BODY IN THE NIPPLE (METAL?) CALLED HOSP AND BROUGHT THE NIPPLES BACK. THE PRODUCT WAS REPLACED WITH NO KNOWN PT SEQUELAE FROM THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMILAC INFANT NIPPLE AND RING SIMILAC INFANT NIPPLE AND RING FNN ROSS PRODUCTS DIVISION ABBOTT LABS #079 151865950

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DAY Other