BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 8238033 · Received January 10, 2019

    Report

    Report Number
    3011109575-2019-00099
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    May 1, 2017
    Report Date
    January 8, 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
    TX, 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

    CONSUMER REPORTED THAT ONE U BY KOTEX SLEEK REGULAR TAMPONS FELL APART INSIDE OF HER UPON REMOVAL. SHE RECEIVED MEDICAL ATTENTION TO REMOVE REMAINING PIECES AND VAGINAL DISCHARGE. PHYSICIAN CONFIRMED THERE WERE NO PIECES LEFT, BUT RECEIVED NO DIAGNOSIS OR PRESCRIPTIONS FOR VAGINAL DISCHARGE. SHE ALSO REPORTED THAT SOMETIME LATER SHE EXPERIENCED PELVIC PAIN AND 2 CYCLES A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26409 U BY KOTEX SLEEK TAMPON, MENSTUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C. V. REGULAR 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR