BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAC VOLU-FEED

    MDR report key: 6686082 · Received July 5, 2017

    Report

    Report Number
    6686082
    Event Type
    Malfunction
    Date Received
    July 5, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 12, 2017
    Manufacturer
    ABBOTT NUTRITION ABBOTT LABORATORIES
    Product Code
    FNN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFANT'S FEEDING AND MEDICATIONS PREPARED IN DISPOSABLE NURSER/BOTTLE. UPON INVERTING BOTTLE TO FEED INFANT, SMALL AMOUNT OF FORMULA AND MEDICATIONS LEAKED OUT SMALL CRACK IN NURSER/BOTTLE. CONTENTS OF NURSER/BOTTLE WERE PLACED INTO NEW NURSER/BOTTLE AND FED WITHOUT FURTHER INCIDENT. AFFECTED NURSER/BOTTLE AND ANOTHER UNOPENED PACKAGE THAT APPEARED TO HAVE SAME ISSUE WERE SAVED FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468297 SIMILAC VOLU-FEED NIPPLE, LAMBS FEEDING FNN ABBOTT NUTRITION ABBOTT LABORATORIES 00180 76081LS00 094 04

    Patients

    Seq Age Sex Outcome Treatment
    1