BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 8238220 · Received January 10, 2019

    Report

    Report Number
    3011109575-2019-00244
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 17, 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
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION HAS BEEN RECEIVED. LOT NUMBER, FOLLOW-UP 1, FOLLOW UP TYPE, METHODS, RESULTS, AND CONCLUSION CODES THE MANUFACTURING FACILITY IS CONDUCTING A REVIEW OF THE DHR (DEVICE HISTORY RECORD) AND SUPPORTING QUALITY RECORDS.

    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

    THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED THAT TWO U BY KOTEX SLEEK REGULAR TAMPONS UNRAVELED INSIDE OF HER DURING REMOVAL AND BROKE INTO MULTIPLE PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26661 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C. V. REGULAR NN821313A 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR