BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 511288 · Received February 13, 2004

    Report

    Report Number
    2381757-2004-00001
    Event Type
    Other
    Date Received
    February 13, 2004
    Date of Event
    January 21, 2004
    Report Date
    January 26, 2004
    Manufacturer
    KIMBERLY-CLARK CORP., CONSUMER PRODUCT MILLS
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORPORATION RECEIVED NOTICE IN 2004 ALLEGING THAT THE PT CLAIMED TO HAVE EXPERIENCED EXTREME CRAMPING AND DIZZINESS. THE PT VISITED AN E.R. AND A DOCTOR FOUND A SMALL PORTION OF A TAMPON LEFT IN THE VAGINA WHICH PT BELIEVED TO HAVE CAUSED THE INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS UNSCENTED MENSTRUAL TAMPON - REGULAR ABSORBENCY HEB KIMBERLY-CLARK CORP., CONSUMER PRODUCT MILLS NA AC325721F

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other