BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2465514 · Received February 17, 2012

    Report

    Report Number
    9611594-2012-00019
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Report Date
    February 7, 2012
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K103311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. INFO 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

    CONSUMER STATED TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE HER. SHE WAS ABLE TO REMOVE REMAINING PIECES ON HER OWN, WHICH WAS CONFIRMED BY HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT S. DE R.L. DE C.V. REGULAR AA118901A1019

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR