BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 428778 · Received November 22, 2002

    Report

    Report Number
    2381757-2002-00006
    Event Type
    Other
    Date Received
    November 22, 2002
    Date of Event
    October 7, 2002
    Report Date
    November 22, 2002
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 11/11/2002, KIMBERLY-CLARK CORP RECEIVED A COMPLAINT THAT PT CLAIMED PT BECAME ILL AND WAS DIAGNOSED WITH TOXIC SHOCK SYNDROME. THE PT ALLEGES THAT ON 11/5, PT BECAME NAUSEOUS, FELT CHEST PAINS, AND DEVELOPED A RASH ON THE INSIDE OF THEIR LEGS. THE PT WAS HOSPITALIZED. THE PT WAS ALLEGEDLY USING KOTEX SECURITY TAMPONS DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS UNSCENTED MENSTRUAL - SUPER PLUS ABSORBENCY TAMPONS HEB KIMBERLY-CLARK CORP. TUBS36 AC222527X0932

    Patients

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