BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 3131851 · Received May 29, 2013

    Report

    Report Number
    2381757-2013-00021
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 26, 2013
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE CONSUMER RETURNED UNUSED SAMPLES ON (B)(4) 2013. DEVICE PROBLEM IS ALREADY KNOWN, NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT HER TAMPON ELONGATED DURING REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE WAS ABLE TO REMOVE THE REMAINING PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237143 U BY KOTEX SLEEK TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL REGULAR AC300966X2343

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR