BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 1813406 · Received August 19, 2010

    Report

    Report Number
    9611594-2010-00018
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 19, 2010
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE CONSUMER DID NOT PROVIDE LOT CODE INFO. SAMPLES WERE NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THIS IS A NON-U.S. PRODUCT PROBLEM. THE MALFUNCTION OCCURRED IN (B)(6). CONSUMER STATED ON THREE SEPARATE OCCASIONS WHEN REMOVING A TAMPON FROM HER VAGINA, A PART OF THE TAMPON REMAINED INSIDE HER. THE TAMPON STRETCHES AND COMES OFF AT THE END OF THE TAMPON.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1