BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2141594 · Received May 27, 2011

    Report

    Report Number
    9611594-2011-00067
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 13, 2011
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN 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

    THIS IS A NON-US EVENT. THIS MALFUNCTION OCCURRED IN (B)(6). CONSUMER STATES TAMPON FELL APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE HER. SHE BELIEVES SHE HAD REMOVED ALL REMAINING PIECES. SHE TOOK MIDOL FOR CRAMPS. SHE WILL CONTACT HER DOCTOR IF CRAMPING PERSISTS OR SHE FEELS ADDITIONAL PIECES REMAINING INSIDE HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPONS HEB AVENT SA DE R.L. DE C.V. REGULAR AA108001A

    Patients

    Seq Age Sex Outcome Treatment
    1