BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 8234257 · Received January 10, 2019

    Report

    Report Number
    3011109575-2019-00100
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    October 17, 2018
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C. V.
    Product Code
    HEB
    UDI-DI
    00036000998368
    PMA / PMN Number
    K112635
    Removal / Correction Number
    3003701733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE VERIFIED THAT THE REPORTED LOT NUMBER IS PART OF THE U BY KOTEX SLEEK TAMPONS, REGULAR ABSORBENCY 2018 RECALL. NO ADDITIONAL ANOMALIES DURING THE MANUFACTURE OF THE PRODUCT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION WERE DISCOVERED DURING A REVIEW CONDUCTED ON DECEMBER 18, 2018 OF THE DEVICE HISTORY RECORD (DHR) AND SUPPORTING QUALITY RECORDS AT THE MANUFACTURING FACILITY IN (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT SEVEN U BY KOTEX SLEEK REGULAR TAMPONS FELL APART INSIDE OF HER UPON REMOVAL. SHE EXPERIENCED BLEEDING, NAUSEA AND HOT FLASHES. SHE VISITED HER DOCTOR WHO PERFORMED AN ULTRASOUND AND FOUND BLOOD IN HER UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29912 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C. V. REGULAR NN805813A1209 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR