BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 340963 · Received July 3, 2001

    Report

    Report Number
    2381757-2001-00002
    Event Type
    Injury
    Date Received
    July 3, 2001
    Date of Event
    March 3, 2000
    Report Date
    July 3, 2001
    Manufacturer
    KIMBERLY-CLARK CORP/CONSUMER PRODUCTS MILL
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    KIMBERLY-CLARK CORP RECEIVED NOTICE ON 6/4/2001 ALLEGING THAT ON OR ABOUT 3/2000, PT EXPERIENCED FLU-LIKE SYMPTOMS. PT WAS HOSPITALIZED 3 DAYS LATER AND DIAGNOSED WITH TOXIC SHOCK SYNDROME. PT WAS RELEASED 9 DAYS LATER. PT WAS ALLEGEDLY USING KOTEX SUPER ABSORBENCY MENTRUAL TAMPONS WHEN THEY BECAME ILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30094 KOTEX SECURITY TAMPONS UNSCENTED MENSTRUAL TAMPONS HEB KIMBERLY-CLARK CORP/CONSUMER PRODUCTS MILL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R