BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 3230718 · Received July 17, 2013

    Report

    Report Number
    2381757-2013-00033
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THIS IS A NON-US EVENT. THE EVENT OCCURRED IN (B)(6). THE CONSUMER STATED ON THREE SEPARATE OCCASIONS HER TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330733 U BY KOTEX SLEEK TAMPON HEB REGULAR AC300366X0353

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR