BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 8276109 · Received January 24, 2019

    Report

    Report Number
    3011109575-2019-00113
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    January 1, 2018
    Report Date
    January 24, 2019
    Manufacturer
    K-C AFC MANUFACTURING, S..DE R.L. DE C..V.
    Product Code
    HEB
    UDI-DI
    00036000998368
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED.

    Description of Event or Problem · 1

    PURCHASED 90 COUNT BOX OF U BY KOTEX SLEEK TAMPONS AND TAMPON FELL APART WHEN BEING REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66908 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S..DE R.L. DE C..V. REGULAR 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1