BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX NATURAL BALANCE

    MDR report key: 3230724 · Received July 17, 2013

    Report

    Report Number
    2381757-2013-00031
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 21, 2013
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 SHE EXPERIENCED DISCOMFORT UPON INSERTION OF HER TAMPON. WHEN SHE REMOVED THE TAMPON, THERE APPEARED TO BE TWO PLEDGETS ATTACHED. SHE INDICATED THAT THIS OCCURRED ON SEVERAL OCCASIONS. SHE ALSO STATED THAT SHE VISITED HER DOCTOR FOR AN IUD REMOVAL AND REMOVED HER TAMPON FOR HER VISIT. UPON INSPECTION, HER DOCTOR FOUND AN ADDITIONAL PLEDGET INSIDE OF HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330735 KOTEX NATURAL BALANCE TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL SUPER PLUS AC309524X0953

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR