BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST YEARS TEETHER

    MDR report key: 722848 · Received May 10, 2006

    Report

    Report Number
    MW1039118
    Event Type
    Malfunction
    Date Received
    May 10, 2006
    Date of Event
    September 1, 2005
    Report Date
    May 10, 2006
    Manufacturer
    *
    Product Code
    KKO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON INGESTED THE BACTERIA IN THE FIRST YEARS TEETHER THAT WAS RECALLED. HE HAS UNDERGONE 2 PROCEDURES AND MORE WILL GO ON THIS WEEK. I CONTACTED THE CO AND THEY ARE STILL NOT REPORTING ANY SERIOUS ILLNESS. THERE HAVE BEEN LEAKING REPORTS, BITE THROUGH, AND CUTS. MY SON IS STILL SERIOUSLY ILL. PLEASE HELP ME HELP OTHER PARENTS REGARDING THE SERIOUS REACTIONS OF THIS BACTERIA THAT MY SON INGESTED. THE CO HAS NOT BEEN FORTHRIGHT WITH US TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST YEARS TEETHER * KKO * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other