BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS SUPER PLUS

    MDR report key: 1821438 · Received August 27, 2010

    Report

    Report Number
    9611594-2010-00022
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 26, 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 Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. CONSUMER WAS REQUESTED TO RETURN SAMPLES TO MFR.

    Description of Event or Problem · 1

    THIS IS A NON-US PRODUCT PROBLEM. THE MALFUNCTION OCCURRED IN (B)(6). CONSUMER STATED SHE REMOVED A TAMPON AND FIBERS WERE LEFT INSIDE HER BECAUSE THE TAMPON DID NOT COME OUT IN ONE PIECE. SHE CONFIRMED A DOCTOR REMOVED THE FIBERS AND SHE FEELS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention