BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAC

    MDR report key: 3365255 · Received September 19, 2013

    Report

    Report Number
    3365255
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    August 31, 2013
    Report Date
    September 13, 2013
    Manufacturer
    ABBOTT NUTRITION ABBOTT LABORATORIES
    Product Code
    FNN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAFF OPENED PACKAGE, INSPECTED NIPPLE PRIOR TO PLACING NIPPLE ON BOTTLE FOR FEEDING AND NOTED PRESENCE OF WHAT THEY DESCRIBED AS "A BUG." ALL NIPPLES WITH DATE (B)(4) 2016 AND NUMBER (B)(4) WERE REMOVED FROM NURSERY TO BE RETURNED TO COMPANY REPRESENTATIVE AND REPLACED. THE PRODUCT BEING REPORTED ON WAS RETURNED TO COMPANY REPRESENTATIVE ON FRIDAY, (B)(4) 2013. THE NIPPLE WAS NOT USED ON A BABY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474219 SIMILAC INFANT NIPPLE AND RING FNN ABBOTT NUTRITION ABBOTT LABORATORIES 30105SG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other