BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 1872371 · Received October 8, 2010

    Report

    Report Number
    9611594-2010-00055
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 10, 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 Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. SAMPLES WERE NOT RETURNED BY CONSUMER.

    Description of Event or Problem · 1

    THE CONSUMER INDICATED UPON REMOVING THE TAMPON A PIECE REMAINED INSIDE OF HER. SHE WAS ABLE TO REMOVE THE PIECE ON HER OWN AND DID NOT SEEK MEDICAL ATTENTION.

    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. SUPER ABSORBENCY SBC16122X

    Patients

    Seq Age Sex Outcome Treatment
    1