BEUDAMED
    FDA Adverse Event Death Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 212641 · Received March 5, 1999

    Report

    Report Number
    2381757-1999-00002
    Event Type
    Death
    Date Received
    March 5, 1999
    Date of Event
    January 1, 1998
    Report Date
    March 5, 1999
    Manufacturer
    KIMBERLY-CLARK CORP. CONSUMER PRODUCTS MILL
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    KIMBERLY-CLARK CORP REC'D NOTICE ON 02/10/1999 ALLEGING THAT DURING 01/1998, PT BECAME ILL, WAS HOSPITALIZED AND DIED AS A RESULT OF TOXIC SHOCK SYNDROME. PT WAS ALLEGEDLY USING KOTEX SECURITY MENSTRUAL TAMPONS.

    Devices

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

    Patients

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