BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX NATURAL BALANCE

    MDR report key: 2931129 · Received January 28, 2013

    Report

    Report Number
    2381757-2013-00004
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 27, 2012
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INDICATED THAT HER TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE DID NOT REALIZE IT SEPARATED UNTIL A SMALL PIECE WAS DISPELLED AFTER SEXUAL INTERCOURSE. SHE IS PLANNING TO VISIT HER DOCTOR TO ENSURE THERE ARE NO REMAINING PIECES OR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37539 KOTEX NATURAL BALANCE TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL SUPER PLUS AC220522X0054

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR