BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 3232348 · Received December 11, 2012

    Report

    Report Number
    3007303617-2012-00043
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 18, 2012
    Manufacturer
    QINGDAO PB CO. LTD
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CONSUMER STATED ON TWO SEPARATE OCCASIONS HER TAMPON CAME APART AND TAMPON PIECES REMAINED INSIDE OF HER. SHE INDICATED THAT THE INSIDE OF THE TAMPONS APPEARED TO COME OUT, LEAVING THE OUTER AREA INSIDE OF HER. SHE BELIEVES SHE WAS ABLE TO REMOVE THE REMAINING PIECES, BUT PLANS TO FOLLOW-UP WITH HER DOCTOR TO CONFIRM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPON HEB QINGDAO PB CO. LTD REGULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR