BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 3232347 · Received December 11, 2012

    Report

    Report Number
    3007303617-2012-00042
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 12, 2012
    Manufacturer
    QINGDAO PB CO. LTD
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 INDICATED THAT HER TAMPON CAME APART AND TAMPON PIECES REMAINED INSIDE OF HER. SHE WAS NOT CERTAIN THAT ALL PIECES WERE REMOVED, BUT STUCK ANOTHER TAMPON INSIDE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR