BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 2771536 · Received October 4, 2012

    Report

    Report Number
    9611594-2012-00115
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    January 1, 2012
    Report Date
    September 6, 2012
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K112365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CONSUMER INDICATED THE LAST THREE TAMPONS WITHIN HER PACKAGE HAVE UNROLLED UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX SLEEK TAMPON HEB AVENT S. DE R.L. DE C.V. AA203801A1227

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR