BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 2070795 · Received April 14, 2011

    Report

    Report Number
    2381757-2011-00005
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS ONLY A PARTIAL LOT CODE WAS PROVIDED. INFO 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 THAT THE TAMPON FELL APART AS SHE WAS REMOVING IT, AND SHE WAS CONCERNED ABOUT MATERIAL THAT MIGHT BE LEFT INSIDE.

    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 AC02

    Patients

    Seq Age Sex Outcome Treatment
    1