BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2213853 · Received August 4, 2011

    Report

    Report Number
    9611594-2011-00089
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K103311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A 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

    THIS IS A NON-US EVENT. THE MALFUNCTION OCCURRED IN (B)(6). CONSUMER STATES A TAMPON CAME APART INSIDE HER AND SHE HAD TO REMOVE THE REMAINING PIECES INSIDE HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT SA DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1