BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX NATURAL BALANCE

    MDR report key: 3122421 · Received May 21, 2013

    Report

    Report Number
    2381757-2013-00019
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 24, 2013
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT CODE WAS NOT PROVIDED. 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 HER TAMPON APPEARED TO CONTAIN MOLD. SHE STATED THAT SHE NOTICED THE APPLICATOR WAS CRACKED. SHE INSERTED THE TAMPON AND UPON REMOVAL OF THE APPLICATOR NOTICED THERE WAS A BLACK SUBSTANCE ON THE APPLICATOR. SHE THEN REMOVED THE TAMPON AND THERE APPEARED TO BE A BLACK SUBSTANCE ON THE TAMPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224524 KOTEX NATURAL BALANCE TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL SUPER PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR