BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 7428823 · Received April 13, 2018

    Report

    Report Number
    3011109575-2018-00042
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    March 17, 2018
    Report Date
    April 13, 2018
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998405
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) AND QUALITY RECORDS WERE REVIEWED. THESE DOCUMENTS DEMONSTRATE THAT PROCEDURES WERE CORRECTLY FOLLOWED. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS WILL BE INITIATED AND CORRECTIVE ACTION TAKEN. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A REGULAR BASIS OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. IN ADDITION, COMPLAINTS ARE ALSO MONITORED FOR TRENDING ON A MONTHLY CADENCE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CONSUMER STATED BY EMAIL THAT DURING REMOVAL A TAMPON CAME APART AND PIECES REMAINED INSIDE. THERE HAVE BEEN FOUR ATTEMPTS (19 MAR 2018, 27 MAR 2018, 03 APR 2018, AND 11 APR 2018) BY EMAIL TO CONTACT THE CONSUMER FOR MORE INFORMATION, BUT WE HAVE NOT BEEN SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273566 U BY KOTEX CLICK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V SUPER NN734914D 00036000998405

    Patients

    Seq Age Sex Outcome Treatment
    1