BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX NATURAL BALANCE

    MDR report key: 3230715 · Received July 17, 2013

    Report

    Report Number
    2381757-2013-00030
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 19, 2013
    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

    A MANUFACTURING DOCUMENT AND RECORDS REVIEW WAS PERFORMED OF THE COMPLAINT LOT #AC312326X0457. DOCUMENTATION AND RECORDS ASSESSED INCLUDE: DEVICE HISTORY, MANUFACTURING, QA AUDIT, MICRO, OPERATOR ENTRY, AND PRODUCTION LINE LOGS, RAW MATERIAL AND FINISHED PRODUCT RELEASE TESTING RECORDS. THIS REVIEW OBSERVED A KNIFE CHANGE WAS PERFORMED SAME HOUR AS THE COMPLAINT LOT. AN UNCLEAN KNIFE CUT CAN CAUSE THE FIBERS TO BE LOOSE AN POSSIBLY AFFECT THE COMPRESSION OF THE TAMPON. NO OTHER ANOMALIES WERE OBSERVED THAT COULD HAVE CONTRIBUTED OR CAUSED THE REPORTED EVENT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT THE STRING FELL OFF WHEN SHE ATTEMPTED TO REMOVE HER TAMPON. SHE WAS UNABLE TO REMOVE AND HAD TO VISIT THE ER FOR REMOVAL BY A PHYSICIAN. UPON REMOVAL BY A PHYSICIAN, THE TAMPON SEPARATED. THE PHYSICIAN WAS ABLE TO REMOVE THE REMAINING PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330705 KOTEX NATURAL BALANCE TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL SUPER AC312326X0457

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR