BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK SUPER AND REGULAR TAMPONS

    MDR report key: 1811012 · Received August 10, 2010

    Report

    Report Number
    9611594-2010-00017
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 9, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER STATED UPON PULLING THE TAMPON OUT, A PORTION OF THE TOP OF THE TAMPON TORE OFF AND REMAINED IN HER BODY AND HAD TO BE REMOVED BY HER OB/GYN. THE CONSUMER INDICATED THIS EVENT HAPPENED ON TWO SEPARATE OCCASIONS, ONCE USING A SUPER ABSORBENCY TAMPON AND ONCE USING A REGULAR ABSORBENCY TAMPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK SUPER AND REGULAR TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention