BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX FITNESS

    MDR report key: 7113564 · Received December 13, 2017

    Report

    Report Number
    3011109575-2017-00098
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 13, 2017
    Manufacturer
    K-C AFC MANUFACTURING, S. DE. R.L. DE C.V.
    Product Code
    HEB
    UDI-DI
    00036000999655
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    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 RECORDS CAN BE PERFORMED. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A REGULAR CADENCE OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. IN ADDITION, ALL COMPLAINTS ARE ALSO MONITORED FOR TRENDING ON A MONTHLY BASIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT HER TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. THE CONSUMER ALSO REPORTED VAGINAL PAIN AND IS CONCERNED ABOUT A POSSIBLE URINARY TRACT INFECTION. NO DOCTOR WAS SEEN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895165 U BY KOTEX FITNESS TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE. R.L. DE C.V. REGULAR 00036000999655

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR