BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 556471 · Received November 24, 2004

    Report

    Report Number
    2381757-2004-00005
    Event Type
    Other
    Date Received
    November 24, 2004
    Date of Event
    November 16, 2004
    Report Date
    November 24, 2004
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORPORATION RECEIVED NOTICE IN 2004 ALLEGING THAT THE PT HAD AN INFECTION. ATTENDING TO THE COMPLAINT, THE PT VISITED THE EMERGENCY ROOM AND HALF A TAMPON WAS FOUND INSIDE THE PT, WHICH WAS ALLEGEDLY THE CAUSE OF THE INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other