BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 1960826 · Received December 17, 2010

    Report

    Report Number
    9611594-2010-00106
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. CONSUMER DID NOT RETURN PRODUCT FOR EVALUATION.

    Description of Event or Problem · 1

    CONSUMER WAS REMOVING A TAMPON AND THE TAMPON BROKE INSIDE HER. UPON TAMPON REMOVAL, A PIECE OF THE TAMPON REMAINED INSIDE HER. SHE REMOVED THE REMAINING PIECE 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. SUPER AA011101B2005

    Patients

    Seq Age Sex Outcome Treatment
    1