BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS - SUPER ABSORBENCY

    MDR report key: 613828 · Received June 14, 2005

    Report

    Report Number
    2381757-2005-00010
    Event Type
    Other
    Date Received
    June 14, 2005
    Date of Event
    May 9, 2005
    Report Date
    June 14, 2005
    Manufacturer
    KIMBERLY CLARK CORPORATION
    Product Code
    KNT
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORPORATION RECEIVED NOTICE IN 2005 ALLEGING THAT THE PATIENT EXPERIENCE AN INFECTION WITH DIZZINESS/CRAMPING/NAUSEA. THE PATIENT ALLEGES THAT A PORTION OF A TAMPON REMAINED INSIDE THEM FOR TEN DAYS BEFORE COMING OUT WHEN THEY WERE USING THE BATHROOM. THE PATIENT ALLEGES THAT THEIR DOCTOR FOUND BACTERIAL CELLS AND GAVE THEM AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS - SUPER ABSORBENCY UNSCENTED MENSTRUAL TAMPONS KNT KIMBERLY CLARK CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other