BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 3122297 · Received May 21, 2013

    Report

    Report Number
    9611594-2013-00056
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 18, 2013
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 STATED THAT HER TAMPON HAD NO STRING AND REMAINED INSIDE OF HER. SHE VISITED THE ER AND THE PHYSICIAN REMOVED THE TAMPON USING A SPECULUM. NO MEDICATION WAS PRESCRIBED, HOWEVER, SHE IS TAKING ADVIL FOR VAGINAL SORENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224080 U BY KOTEX SLEEK TAMPON HEB AVENT S. DE R.L. DE C.V. SUPER AA212901A2353

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR