BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 2900216 · Received January 7, 2013

    Report

    Report Number
    9611594-2013-00005
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 8, 2012
    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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT CODE WAS NOT PROVIDED. 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

    THIS IS A NON-US EVENT. THE EVENT OCCURRED IN (B)(6). THE CONSUMER INDICATED THAT HER TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6948 U BY KOTEX CLICK TAMPON HEB AVENT S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1