BEUDAMED
    FDA Adverse Event Death Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 428211 · Received November 15, 2002

    Report

    Report Number
    2381757-2002-00005
    Event Type
    Death
    Date Received
    November 15, 2002
    Date of Event
    December 10, 2000
    Report Date
    November 4, 2002
    Manufacturer
    KIMBERLY - CLARK CORP. CONSUMER PRODUCTS MILL
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON OCTOBER 16, 2002, KIMBERLY-CLARK CORPORATION RECEIVED A COMPLAINT ALLEGING THAT PATIENT HAD DIED AS THE RESULT OF AN INFECTION RELATED TO TOXIC SHOCK SYNDROME. ACCORDING TO THE COMPLAINT, PATIENT INITIALLY EXPERIENCED FLU LIKE SYMPTOMS IN 2000. SHORTLY THEREAFTER, PT WAS HOSPITALIZED, AND LATER PT PASSED AWAY. THE PATIENT WAS ALLEGEDLY USING KOTEX SECURITY TAMPONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS UNSCENTED MENSTRUAL TAMPON - SIZE UNKNOWN HEB KIMBERLY - CLARK CORP. CONSUMER PRODUCTS MILL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| H| L| R| S