BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 1882469 · Received October 21, 2010

    Report

    Report Number
    9611594-2010-00069
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. SAMPLES WERE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER STATED AS SHE REMOVED A TAMPON THE TAMPON CAME APART AND SOME OF THE TIP OF THE TAMPON REMAINED INSIDE HER BODY. SHE REMOVED THE REMAINING PIECE HERSELF.

    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 AA019801A1257

    Patients

    Seq Age Sex Outcome Treatment
    1