BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX NATURAL BALANCE

    MDR report key: 3131780 · Received May 29, 2013

    Report

    Report Number
    2381757-2013-00020
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 25, 2013
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE STRING DETACHED FROM HER TAMPON CAUSING THE TAMPON TO COME APART UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234772 KOTEX NATURAL BALANCE TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL SUPER PLUS AC303826X2253

    Patients

    Seq Age Sex Outcome Treatment
    1