BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE FIRST YEARS COOL ANIMAL TEETHER

    MDR report key: 682058 · Received February 9, 2006

    Report

    Report Number
    MW1037980
    Event Type
    Malfunction
    Date Received
    February 9, 2006
    Date of Event
    October 15, 2005
    Report Date
    February 9, 2006
    Manufacturer
    THE FIRST YEARS
    Product Code
    KKO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE PROBLEM WAS THAT RPTR'S SON HAD ONE OF THE FIRST YEARS TEETHER, THE FISH TO BE SPECIFIC. RPTR'S HUSBAND NOTICED THAT IT WAS LEAKING AND SUBSEQUENTLY TOOK IT AWAY. RPTR DOESN'T KNOW HOW LONG SON HAD THE TEETHER BEFORE THE PROBLEM WAS DISCOVERED. REPORTED TO THE FIRST YEARS THE PROBLEM AND THEY SENT ME A NEW TEETHER, THE ZEBRA. RPTR NEVER ALLOWED HIM TO USE THIS TEETHER. RPTR RECENTLY HEARD OF THE RECALL OF THE TEETHERS AND IS QUITE NERVOUS AS TO WHAT TYPE OF PROBLEMS CAN BE CAUSED BY THIS BACTERIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR