BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 1881430 · Received October 19, 2010

    Report

    Report Number
    2381757-2010-00007
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILLS
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. SAMPLES WERE NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    CONSUMER STATED SHE USED A TAMPON DAYS AGO AND TODAY A BLOOD SOAKED PIECE OF TAMPON CAME OUT OF HER. SHE INDICATED SHE HAS HAD AN UNUSUAL PAIN FOR THE LAST 2 DAYS AND THINKS THE PAIN MAY BE A CYST. THE CONSUMER WILL NOT SEE A DOCTOR AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILLS REGULAR AC007325X1717

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR