BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 2082142 · Received April 27, 2011

    Report

    Report Number
    2381757-2011-00006
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 20, 2011
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS IN REVIEW. 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 THAT THE TAMPON APPLICATOR HAD AN EXTRA PLASTIC TAG ON IT AND WHILE INSERTING THE TAMPON THE TAG LEFT A GASH IN THE LABIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS HEB- UNSCENTED MENSTRUAL TAMPON HEB KIMBERLY-CLARK CORPORATION SUPER PLUS AC028152893267

    Patients

    Seq Age Sex Outcome Treatment
    1