BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOTEX SECURITY TAMPONS - SUPER

    MDR report key: 1133191 · Received August 21, 2008

    Report

    Report Number
    2381757-2008-00004
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    KIMBERLY-CLARK CORP., CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO KIMBERLY-CLARK FOR EVAL NOR WAS A LOT NUMBER PROVIDED BY THE CONSUMER. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE. THIS PRODUCT INCIDENT HAS BEEN INCORPORATED INTO THE KIMBERLY-CLARK COMPLAINT TRENDING SYSTEM WHICH IS USED TO IDENTIFY REPETITIVE ISSUES THAT MAY REQUIRE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT SHE WAS USING TAMPONS IN 2008 AND BECAME ILL WITH ALLEGED TSS OR OTHER ILLNESS. SHE STARTED TO FEEL ILL PRIOR TO HER VACATION AND DURING THE VACATION, SHE HAD A BAD HEADACHE, FEVER OF 103 DEGREES AND THOUGHT SHE HAD THE FLU. CONSUMER FLEW HOME AND SUBSEQUENTLY WENT TO THE DOCTOR ON THE SAME MONTH. CONSUMER REPORTS THAT BLOOD AND URINE TESTS WERE TAKEN AND THE URINE WAS POSITIVE FOR STAPHYLOCOCCUS. THE DOCTOR PRESCRIBED MEDICATION. CONSUMER WENT BACK TO THE DOCTOR THE NEXT DAY AS HER TEMPERATURE HAD NOT GONE DOWN. DOCTOR DID AN MRI AND SCAN. PT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS - SUPER HEB-UNSCENTED MENSTRUAL TAMPONS HEB KIMBERLY-CLARK CORP., CONWAY MILL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening