BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAC INFANT NIPPLE & RING

    MDR report key: 7721917 · Received July 26, 2018

    Report

    Report Number
    7721917
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Date of Event
    July 14, 2018
    Report Date
    July 20, 2018
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FNN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN WHO WAS FEEDING BABY NOTICED THAT HE TOOK HIS PO VOLUME FASTER THAN THE PREVIOUS CARE TIMES. AFTER 30 MLS HAD BEEN NIPPLED, RN REMOVED THE NIPPLE FROM THE BABY'S MOUTH TO BURP AT WHICH TIME SHE NOTICED THE NIPPLE WAS MISSING A CHUNK OUT OF THE SIDE OF IT. THE BABY DID NOT CHOKE OR DESAT WHILE EATING. THE MISSING PIECE OF THE NIPPLE WAS UNABLE TO BE FOUND. PHOTOGRAPH ATTACHED TO THIS REPORT. ====================== MANUFACTURER RESPONSE FOR INFANT NIPPLE AND RING, SIMILAC INFANT NIPPLE & RING (PER SITE REPORTER). ====================== SPOKE TO MANUFACTURER WHO ADVISES THAT THEY WILL BE SENDING A BOX TO SEND THE DEVICE BACK IN. THEY DID ASK THAT I ALSO SEND AN UNOPENED DEVICE ALONG WITH THE DEFECTIVE DEVICE BACK FOR LABORATORY COMPARISON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566001 SIMILAC INFANT NIPPLE & RING NIPPLE, LAMBS FEEDING FNN ABBOTT LABORATORIES 88075SG00

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA