BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 8160162 · Received December 13, 2018

    Report

    Report Number
    3011109575-2018-00179
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 16, 2018
    Report Date
    December 13, 2018
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V.
    Product Code
    HEB
    UDI-DI
    00036000998382
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE ATTEMPTED TO FOLLOW UP WITH THE CONSUMER THREE TIMES ((B)(6)2018) BUT HAVE NOT BEEN SUCCESSFUL. REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND OTHER QUALITY RECORDS CONFIRMED NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT UPON REMOVAL, A SLEEK SUPER PLUS ABSORBENCY TAMPON UNRAVELED AND BROKE INTO TWO PIECES INSIDE HER. SHE WAS ABLE TO REMOVE BOTH PIECES BUT IS UNSURE IF ADDITIONAL PIECES REMAIN. SHE MAY SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000144 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V. SUPER PLUS NN714413B0330 00036000998382

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR