BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOTEX SECURITY

    MDR report key: 215163 · Received March 23, 1999

    Report

    Report Number
    2381757-1999-00003
    Event Type
    Injury
    Date Received
    March 23, 1999
    Date of Event
    February 24, 1999
    Report Date
    March 23, 1999
    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 CORPORATION RECEIVED NOTICE ON 02/24/1999 FROM THE PATIENT, PRIOR TO A DOCTOR VISIT, ALLEGING PATIENT DEVELOPED SYMPTOMS THAT CAN BE INDICATIVE OF TOXIC SHOCK SYNDROME WHILE USING TOXIC SECURITY SUPER PLUS MENSTRUAL TAMPONS. REPORTED SYMPTOMS INCLUDED RED RASH, DIZZINESS, FEVER, DRY LIPS AND HOT MOUTH. PATIENT WAS ALLEGEDLY ADMITTED TO THE HOSPITAL ON 02/24/1999 AFTER HER DOCTOR VISIT. HOSPITAL STAY WAS ALLEGEDLY DUE TO INFECTED FALLOPIAN TUBES CAUSED BY TAMPON USE, AND NOT TSS.BASED ON THE CONVERSATION WITH THE PATIENT, KIMBERLY-CLARK CORPORATION HAS REASON TO QUESTION THE ACCURACY OF CERTAIN INFORMATION PROVIDED TO KIMBERLY-CLARK CORPORATION, AND PATIENT WOULD NOT COOPERATE IN PROVIDING ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization