BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 3203834 · Received July 3, 2013

    Report

    Report Number
    9611594-2013-00070
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT SEVERAL TAMPONS CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE FEELS THAT SHE WAS ABLE TO REMOVE ALL REMAINING PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305482 U BY KOTEX SLEEK TAMPON HEB AVENT S. DE R.L. DE C.V. SUPER PLUS AA233902A1041

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR