BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 2141590 · Received May 27, 2011

    Report

    Report Number
    2381757-2011-00008
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT CODE WAS NOT PROVIDED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER DID NOT RETURN UNUSED PRODUCT FOR EVALUATION.

    Description of Event or Problem · 1

    CONSUMER REPORTED A TAMPON CAME APART INSIDE HER UPON REMOVAL. SHE WAS ABLE TO REMOVE THE REMAINING PIECES HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL SUPER

    Patients

    Seq Age Sex Outcome Treatment
    1