BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS - REGULAR ABSORBENCY

    MDR report key: 1002913 · Received February 11, 2008

    Report

    Report Number
    2381757-2008-00001
    Event Type
    Other
    Date Received
    February 11, 2008
    Date of Event
    January 12, 2008
    Report Date
    January 14, 2008
    Manufacturer
    KIMBERLY-CLARK CORPORATION-CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER DID NOT HAVE ANY PRODUCT FROM THE ORIGINAL PACKAGE/LOT TO RETURN. PRODUCT FROM A DIFFERENT PACKAGE AND LOT WAS RETURNED TO MFR. VISUAL ATTRIBUTE INSPECTION OF RETURNED PRODUCT DID NOT INDICATE DEFECTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT TAMPON PLEDGET FELL APART UPON REMOVAL. ON (B) (6) 2008, CONSUMER WENT TO THE DOCTOR. NO PLEDGET PIECES WERE FOUND AT THAT TIME AND THE CONSUMER WAS TREATED WITH MEDICATION FOR A POSSIBLE INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention