BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS - SUPER ABSORBENCY

    MDR report key: 613812 · Received June 14, 2005

    Report

    Report Number
    2381757-2005-00011
    Event Type
    Other
    Date Received
    June 14, 2005
    Date of Event
    May 6, 2005
    Report Date
    June 14, 2005
    Manufacturer
    KIMBERLY CLARK CORPORATION
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORPORATION RECEIVED NOTICE IN 2005 ALLEGING THAT THE PATIENT EXPERIENCED A BACTERIAL INFECTION. THE PATIENT ALLEGES THAT THE DOCTOR FOUND SMALL PIECES OF TAMPON LEFT BEHIND, WHICH HE FELT WAS THE CAUSE OF THE INFECTION.

    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