BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 3232365 · Received December 11, 2012

    Report

    Report Number
    9611594-2012-00154
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K112365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT THE STRING BROKE ON HER TAMPON, CAUSING THE TAMPON TO BREAK APART AND PIECES TO REMAIN INSIDE OF HER. SHE WAS ABLE TO REMOVE ALL REMAINING PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX SLEEK TAMPON HEB AVENT SA DE R.L. DE C.V. REGULAR AA225101B2111

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR