BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2040015 · Received March 9, 2011

    Report

    Report Number
    9611594-2011-00029
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 25, 2011
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    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 PRODUCT FOR EVAL AS OF THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CONSUMER FELT SHE WAS GETTING A YEAST INFECTION. SHE USED A HOME REMEDY WHICH INVOLVES SOAKING THE TAMPON IN YOGURT, INSERTING IT THEN WAITING A FEW MINUTES AND TAKING HE TAMPON OUT. THE TAMPON DID NOT COME OUT EASILY AND THE CONSUMER STILL HAD PIECES OF TAMPON LEFT INSIDE HER. TWO DAYS LATER, SHE STILL HAS PIECES LEFT INSIDE HER AND HAD PLANS TO GO TO THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT SA DE R.L. DE C.V. UNK (MULTIPAK) AA033901A

    Patients

    Seq Age Sex Outcome Treatment
    1