BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 264521 · Received February 24, 2000

    Report

    Report Number
    2381757-2000-00001
    Event Type
    Injury
    Date Received
    February 24, 2000
    Date of Event
    January 1, 2000
    Report Date
    February 24, 2000
    Manufacturer
    KIMBERLY-CLARK CORP., CONSUMER PRODUCTS MILL
    Product Code
    HEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KIMBERLY-CLARK CORP REC'D NOTICE ON 02/07/2000 ALLEGING THAT DURING 01/2000, PT EXPERIENCED FEVER AND SUNBURN RASH. PT WAS DIAGNOSED WITH TOXIC SHOCK SYNDROME. PT WAS ALLEGEDLY USING KOTEX SUPER PLUS MENSTRUAL TAMPONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R