BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOTEX SECURITY TAMPON (REGULAR)

    MDR report key: 751799 · Received August 18, 2006

    Report

    Report Number
    2381757-2006-00004
    Event Type
    Injury
    Date Received
    August 18, 2006
    Date of Event
    July 12, 2006
    Report Date
    July 27, 2006
    Manufacturer
    KIMBERLY-CLARK CORP. / CONSUMERS PRODUCTS MILL
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT OF THE EVENT. A LETTER AND QUESTIONNAIRE HAVE BEEN SENT REQUESTING ADDITIONAL INFORMATION, BUT NO RESPONSE HAS BEEN RECEIVED TO-DATE. H3, H6: NO EVALUATION COULD BE MADE, NO CONCLUSION COULD BE DRAWN AS NO DEVICE HAS BEEN RETURNED.

    Description of Event or Problem · 1

    KIMBERLY-CLARK CORP. RECEIVED NOTICE ON 07/27/06 FROM A PARENT THAT HER DAUGHTER BECAME PHYSICALLY ILL, VOMITING, EXHIBITING DIZZINESS, AND HIGH FEVER. THE YOUNG WOMAN HAD BEEN USING TAMPONS DURING A SWIM MEET. THE DOCTOR'S DIAGNOSIS DETERMINED THAT THE PATIENT WAS SUFFERING FROM TSS. PATIENT WAS HOSPITALIZED AND PLACED ON ANTIBIOTICS. THE PATIENT HAS BEEN RELEASED FROM THE HOSPITAL AND IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPON (REGULAR) UNSCENTED MENSTRUAL TAMPON HEB KIMBERLY-CLARK CORP. / CONSUMERS PRODUCTS MILL NA AC233021B

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L