BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 8135297 · Received December 5, 2018

    Report

    Report Number
    3011109575-2018-00174
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 5, 2018
    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 · 1

    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

    THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). THE CONSUMER STATED THAT TWO TAMPONS CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE STATED SHE IS CONFIDENT SHE WAS ABLE TO REMOVE THE REMAINING PIECES AND DID NOT SEEK MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974350 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V. REGULAR NN814113B1849 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR