BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 416235 · Received September 13, 2002

    Report

    Report Number
    2381757-2002-00003
    Event Type
    Injury
    Date Received
    September 13, 2002
    Report Date
    September 13, 2002
    Manufacturer
    KIMBERLY-CLARK CORP
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORP RECEIVED NOTICE ON 8/21/2002 ALLEGING THAT SOMETIME IN LATE JULY OR EARLY AUGUST 2002, THE PT EXPERIENCED VOMITING, HOT FLASHES, AND FEVER. THE PT ALLEGED THAT A PIECE OF TAMPON WAS EXTRACTED FROM THEM DURING A VISIT AT A HOSP EMERGENCY ROOM. THE PT REPORTEDLY WAS DIAGNOSED WITH TOXIC SHOCK SYNDROME. THE PT ALLEGED THAT THEY WERE USING KOTEX SECURITY TAMPONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS UNSCENTED MENSTRUAL TAMPONS HEB KIMBERLY-CLARK CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L| R