BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 3782002 · Received April 30, 2014

    Report

    Report Number
    9611594-2014-00028
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 31, 2014
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT HER TAMPON CAME APART UPON REMOVAL AND TAMPON CAME APART UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260842 U BY KOTEX CLICK TAMPON HEB AVENT S. DE R.L. DE C.V. REGULAR AA225901B

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR