BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPON (REGULAR)

    MDR report key: 751211 · Received August 14, 2006

    Report

    Report Number
    2381757-2006-00003
    Event Type
    Other
    Date Received
    August 14, 2006
    Date of Event
    July 19, 2006
    Report Date
    July 20, 2006
    Manufacturer
    ROSTAM LTD.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    KIMBERLY-CLARK CORP REC'D NOTICE ON 07/20/06 FROM A TAMPON USER THAT SHE SAW HER DR IN 2006, COMPLAINING OF A BAD ODOR FROM HER VAGINAL AREA AND VAGINAL DISCHARGE. DURING THE VAGINAL EXAMINATION THE DR ALEGEDLY DISCOVERED A PIECE OF TAMPON MATERIAL LODGED IN HER UPPER CERVIX AREA. THE PT WAS IMMEDIATELY SENT TO THE ER WHERE THE MATERIAL WAS REMOVED AND WAS TREATED WITH ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPON (REGULAR) UNSCENTED MENSTRUAL TAMPON HEB ROSTAM LTD. NA 602316

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other