BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE FIRST YEAR

    MDR report key: 698943 · Received April 6, 2006

    Report

    Report Number
    MW1038439
    Event Type
    Malfunction
    Date Received
    April 6, 2006
    Date of Event
    April 5, 2006
    Report Date
    April 6, 2006
    Manufacturer
    *
    Product Code
    KKO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FLUID LEAKED UNDER NORMAL USE BY PT. APPROXIMATELY 1-2 TABLESPOONS OF LIQUID INGESTED. -AFTER INCIDENT, LEARNED THAT PRODUCT IS UNDER RECALL: SEE FDA RECALL NOTICE P06-21 DATES 02/09/06. POISON CONTROL, PEDIATRICIAN CONTACTED. NO ADVERSE REACTIONS 14 HOURS AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE FIRST YEAR FLOATING FRIEND TEETHER KKO * STYLE # Y1474 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *