BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPON-SUPER PLUS

    MDR report key: 724833 · Received June 12, 2006

    Report

    Report Number
    2381757-2006-00001
    Event Type
    Other
    Date Received
    June 12, 2006
    Report Date
    May 23, 2006
    Manufacturer
    KIMBERLY-CLARK CORP., CONSUMER PRODUCT MILL
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FORM CONTAINS INFORMATION REPORTED TO KIMBERLY-CLARK CORPORATION OR ONE OF ITS SUBSIDIARIES AND MAY NOT, AFTER FURTHER INVESTIGATION, REPRESENT ACTUAL FACT. NEITHER THE SUBMISSION OF THIS OR ANY OTHER INFO CONSTITUTES AN ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    KIMBERLY-CLARK CORPORATION RECEIVED THE FOLLOWING NOTICE ON 05/23/06. THE COMPLAINANT ALLEGED THAT SHE NOTICED A VAGINAL DISCHARGE; WONDERED IF SHE HAD FORGOTTEN TO TAKE THE TAMPON OUT, SEARCHED AND FOUND NOTHING. AFTER A COUPLE MORE WEEKS SHE NOTICED ODOR, PAIN, AND DISCHARGE SO CHECKED AGAIN FOR TAMPON AND ALLEGES THAT SHE PULLED OUT A PORTION OF THE TAMPON. SHE WENT TO HER DOCTOR, RECEIVED PELVIC EXAMINATION, AND NO MORE TAMPON MATERIAL WAS FOUND. COMPLAINANT STATED THAT SHE WAS GIVEN MEDICATION FOR THE INFECTION. ITEM B.3. ABOVE WILL NOT ACCEPT YEAR ONLY AS DIRECTED IN THE INSTRUCTIONS. COMPLAINANT DID NOT GIVE EXACT DATE OF THE INITIAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPON-SUPER PLUS UNSCENTED MENSTRUAL TAMPON HEB KIMBERLY-CLARK CORP., CONSUMER PRODUCT MILL NA AC603822X1739

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other