BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX NATURAL BALANCE

    MDR report key: 2833780 · Received November 15, 2012

    Report

    Report Number
    2381757-2012-00095
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 16, 2012
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT CODE WAS NOT PROVIDED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CONSUMER INDICATED THAT HER TAMPON CAME APART UPON REMOVAL AND TAMPON FIBERS REMAINED INSIDE OF HER. SHE WAS ABLE TO REMOVE THE REMAINING PIECES ON HER OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX NATURAL BALANCE TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL REGULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR