BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 6514857 · Received April 22, 2017

    Report

    Report Number
    3003701733-2017-00006
    Event Type
    Malfunction
    Date Received
    April 22, 2017
    Date of Event
    March 13, 2017
    Report Date
    April 20, 2017
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE CONSUMER EXPLAINED THAT USUALLY SHE USED U BY K CLICK TAMPONS, BUT THIS TIME USED U BY K SLEEK TAMPONS. WHEN REMOVING THE TAMPONS THEY WOULD ELONGATE AND SOMETIMES PIECES OF THE TAMPONS REMAINED INSIDE OF HER. DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT CODE WAS NOT PROVIDED BY THE CONSUMER. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. ROOT CAUSE: A ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT COULD NOT BE CONFIRMED. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS NEEDED AT THIS TIME. PREVENTIVE ACTION: NO PREVENTIVE ACTION NEEDED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE A FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A NON US EVENT. THIS EVENT OCCURRED IN (B)(6). THE CONSUMER EXPLAINED THAT USUALLY SHE USED U BY K CLICK TAMPONS, BUT THIS TIME USED U BY K SLEEK TAMPONS. WHEN REMOVING THE TAMPON THEY WOULD ELONGATE AND PIECES OF THE TAMPONS REMAINED INSIDE OF HER. THIS HAPPENED WITH 5 OF THE TAMPONS. SHE IS SURE THAT SHE WAS ABLE TO REMOVE ALL OF THE PIECES AND DID SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296110 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB KIMBERLY-CLARK CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR