BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2141598 · Received May 27, 2011

    Report

    Report Number
    9611594-2011-00063
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 9, 2011
    Manufacturer
    AVENT S DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN 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

    ON (B)(6) 2011, CONSUMER INDICATED TAMPON CAME APART AS SHE ATTEMPTED TO REMOVE THE PRODUCT AND PIECES REMAINED INSIDE HER. ON (B)(6) 2011, CONSUMER STATED SOME REMAINING TAMPON PIECES EXPELLED NATURALLY FROM HER BODY. SHE DID NOT EXHIBIT ANY SYMPTOMS AND HER DR INDICATED SHE SHOULD TRY AND REMOVE ANY REMAINING PIECES. SHE WAS ABLE TO REMOVE AN ADD'L TAMPON PIECE ON HER OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT S DE R.L. DE C.V. SUPER AA028401B2209

    Patients

    Seq Age Sex Outcome Treatment
    1