BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2040017 · Received March 9, 2011

    Report

    Report Number
    9611594-2011-00027
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED PRODUCT FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THIS IS A NON-US EVENT. THE PRODUCT MALFUNCTION OCCURRED IN (B)(6). CONSUMER WAS REMOVING A TAMPON AND THE TAMPON CAME APART INSIDE HER. CONSUMER INDICATED SOME OF THE PIECES REMAINED INSIDE AFTER REMOVAL OF THE TAMPON WHICH SHE REMOVED HERSELF. CONSUMER WAS EXAMINED AT A CLINIC AND CONFIRMED SHE REMOVED ALL REMAINING PIECES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1