BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRST YEARS

    MDR report key: 707946 · Received April 21, 2006

    Report

    Report Number
    MW4004163
    Event Type
    Injury
    Date Received
    April 21, 2006
    Date of Event
    January 1, 2006
    Report Date
    January 30, 2006
    Manufacturer
    FIRST YEARS
    Product Code
    KKO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT HAS BEEN DIAGNOSED WITH PSEUDOMONAS AERUGINOSA DUE TO POSSIBLE INGESTION OF FLUID FROM A RECALLED FIRST YRS ANIMAL TEETHER. BEFORE DIAGNOSIS, COMPLAINANT STATED THAT HIS SON WAS USING AN ANIMAL TEETHER MFG BY FIRST YRS. COMPLAINANT STATED THAT HIS SON BIT INTO THE TEETHER ABOUT FOUR MONTHS AGO AND HE NOTICED THE LIQUID MISSING. HE CONTACTED POSION CONTROL, WHO INFORMED HIM THAT THE LIQUID INSIDE THE TEETHER WAS NON-TOXIC. SINCE THAT TIME, HIS SON HAS BEEN IN AND OUT OF THE HOSP DUE TO CONTINUOUS COUGHING. DURING THE LAST VISIT TO THE HOSP, HIS SON WAS DIAGNOSED WITH THE ABOVE BACTERIA. UPON READING THE LOCAL NEWSPAPER OVER THE WEEKEND, THE COMPLAINANT REALIZED THE FIRST YRS TEETHER HE HAD PURCHASED FOR HIS SON WAS INVOLVED IN A RECALL. HIS SON WILL BE STARTING THE ANTIBIOTIC CIPRO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Life Threatening