BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIRST YEARS ANIMAL TEETHER

    MDR report key: 964304 · Received January 30, 2006

    Report

    Report Number
    1217805-2006-00001
    Event Type
    Other
    Date Received
    January 30, 2006
    Date of Event
    January 30, 2006
    Report Date
    January 30, 2006
    Manufacturer
    RC2 BRANDS, INC. THE FIRST YEARS
    Product Code
    KKO
    PMA / PMN Number
    PREAMEND
    Removal / Correction Number
    RECALL Z-455/460-6
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2006, WE INITIATED A VOLUNTARY RECALL WITH FDA FOR SIX (6) STYLES OF WATERFILLED TEETHER PRODUCT. ON AUGUST, 14, 06 FDA SENT A LETTER TO ADVISE US THAT THEY CONSIDER THE RECALL TERMINATED. BECAUSE OF THE AMBIGUITY OF THE FDA'S RULES, THE MFR WAS UNAWARE THAT A MEDWATCH REPORT MIGHT BE REQUIRED FOR AN INCIDENT ALREADY REPORTED TO FDA BY THE PT FOR A DEVICE THAT HAS ALREADY BEEN THE SUBJECT OF AN FDA-MONITORED RECALL. BECAUSE THE DEVICE HAS ALREADY BEEN RECALLED, THE MFR SUBMITS THAT NO ADVERSE CONSEQUENCES FLOW FROM THE TIMING OF THIS REPORT.

    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 MFD BY FIRST YRS. COMPLAINANT STATED THAT HIS SON BIT INTO THE TEETHER ABOUT FOUR MONTHS AGO AND HE NOTICED THE LIQUID MISSING. HE CONTACTED POISON CONTROL, WHO INFORMED HIM THAT THE LIQUID INSIDE THE TEETHER WAS NON-TOXIC. SINCE THAT TIME, HIS SON HAS REPORTEDLY BEEN IN AND OUT OF THE HOSPITAL DUE TO CONTINUOUS COUGHING. DURING THE LAST VISIT TO THE HOSP, HIS SON WAS REPORTEDLY 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 REPORTEDLY WILL BE STARTING THE ANTIBIOTIC CIPRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST YEARS ANIMAL TEETHER WATERFILLED TEETHER RING KKO RC2 BRANDS, INC. THE FIRST YEARS Y1473 VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Hospitalization