BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 2884637 · Received December 24, 2012

    Report

    Report Number
    9611594-2012-00156
    Event Type
    Malfunction
    Date Received
    December 24, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 27, 2012
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 THAT HER TAMPON FELL APART UPON 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
    1 U BY KOTEX CLICK TAMPON HEB AVENT S. DE R.L. DE C.V. SUPER PLUS AA222801B

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR