BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2040016 · Received March 9, 2011

    Report

    Report Number
    9611594-2011-00028
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 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
    NC, 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 PRODUCT FOR EVAL AS OF THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CONSUMER HAS HAD STOMACH CRAMPS AND BLEEDING AND WAS SEEN BY HER REGULAR PHYSICIAN FOR THESE SYMPTOMS. SHE HAS HAD PAIN FOR 1 1/2-2 WEEKS. TODAY, SHE FOUND A TAMPON TELESCOPE PIECE INSIDE OF HER BUT WAS ABLE TO REMOVE IT. SHE IS CONCERNED THAT MORE PLASTIC TAMPON PIECES REMAIN INSIDE HER. LAST NIGHT WAS THE LAST TIME SHE WORE A TAMPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT SA DE R.L. DE C.V. SUPER AA007901A1146

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR