BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 1882506 · Received October 22, 2010

    Report

    Report Number
    9611594-2010-00075
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 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
    FL, 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

    CONSUMER STATED AS SHE REMOVED A TAMPON, THE TAMPON CAME APART AND SOME REMAINED INSIDE HER BODY. WHEN SHE USED A SUBSEQUENT TAMPON, THE REMAINING PIECES OF THE PREVIOUS TAMPON CAME OUT.

    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 AA0024001A1315

    Patients

    Seq Age Sex Outcome Treatment
    1