BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2212095 · Received July 8, 2011

    Report

    Report Number
    9611594-2011-00078
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 22, 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 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 UNUSED PRODUCT FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THIS IS NON-US EVENT. THE MALFUNCTION OCCURRED IN (B)(4). CONSUMER STATES TWO TAMPONS CAME APART UPON REMOVAL AND A PIECE OF THE TAMPON REMAINED INSIDE HER. SHE WAS ABLE TO REMOVE THE REMAINING PIECES ON HER OWN.

    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 AA020201A0842

    Patients

    Seq Age Sex Outcome Treatment
    1