BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 8237188 · Received January 10, 2019

    Report

    Report Number
    3011109575-2019-00152
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    October 31, 2018
    Report Date
    January 8, 2019
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C. V.
    Product Code
    HEB
    UDI-DI
    00036000998399
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING FACILITY IS CONDUCTING A REVIEW OF THE DHR (DEVICE HISTORY RECORD) AND SUPPORTING QUALITY RECORDS.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT U BY KOTEX CLICK TAMPONS FELL APART INTO MULTIPLE PIECES UPON REMOVAL. SHE ALSO REPORTED EXPERIENCING A URINARY TRACT INFECTION AND YEAST INFECTION. SHE RECEIVED MEDICAL ATTENTION FOR THE INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28037 U BY KOTEX CLICK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C. V. NN819113A1002 00036000998399

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR