BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOTEX SECURITY TAMPON

    MDR report key: 301966 · Received October 27, 2000

    Report

    Report Number
    2381757-2000-00005
    Event Type
    Injury
    Date Received
    October 27, 2000
    Date of Event
    February 5, 2000
    Report Date
    October 27, 2000
    Manufacturer
    KIMBERLY-CLARK CORP., CONSUMER PRODUCTS MILL
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KIMBERLY-CLARK CORP RECEIVED NOTICE IN 2000 ALLEGING THAT IN 2000, PT EXPERIENCED VOMITING, DIARRHEA, FLU LIKE SYMPTOMS, FEVER, NUMBNESS, INFLAMMATION, EXTREMITIES PAIN AND SWELLING. PT REPORTED THEY WERE 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 TAMPON UNSCENTED MENSTRUAL TAMPON-SUPER PLUS HEB KIMBERLY-CLARK CORP., CONSUMER PRODUCTS MILL NA NA

    Patients

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