BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOTEX NATURAL BALANCE

    MDR report key: 3013409 · Received March 20, 2013

    Report

    Report Number
    2381757-2013-00008
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 18, 2013
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT AVAILABLE; THEREFORE A PRODUCT EVALUATION WAS NOT PERFORMED. A DOCUMENT AND RECORDS REVIEW WAS PERFORMED OF THE REPORTED LOT AC225725X2201. DOCUMENTATION ASSESSED INCLUDES: MANUFACTURING, QA AUDIT, MICRO, OPERATOR ENTRY, AND PRODUCTION LINE LOGS, RAW MATERIAL, FINISHED PRODUCT TESTING AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. THE CAUSE OF THESE EVENTS COULD NOT BE DETERMINED. THE LINKAGE OF CAUSALITY TO THE DEVICE WAS ASSESSED AS POSSIBLE BASED ON THE ABSENCE OF SUFFICIENT INFORMATION. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    THE CONSUMER INDICATED THAT SHE DEVELOPED A RASH, BACTERIAL VAGINOSIS AND A URINARY TRACT INFECTION AFTER TAMPON USAGE. SHE ALSO INDICATED THAT SHE SUFFERED TWO MISCARRIAGES OVER THE PAST 4 MONTHS. THE CONSUMER STATED THAT SHE DEVELOPED AN ITCHY RASH IN THE SMALL OF HER BACK, WHICH CONSISTED OF RED RAISED BUMPS, SHORTLY AFTER USING TAMPONS ABOUT FOUR MONTHS AGO. DURING THIS TIME, SHE ALSO EXPERIENCED FEVER, CHILLS, SEVERE PAIN AND ACHING IN HER LEGS, BACK, STOMACH AND BUTTOCKS. THE RASH EVENTUALLY CLEARED. HOWEVER, THE CONSUMER'S HUSBAND INDICATED THAT HE ALSO DEVELOPED A SORE THROAT AND RASH ON HIS ARMS WHICH HE ASSUMED WAS TRANSFERRED FROM HIS WIFE. THE CONSUMER ALSO INDICATED THAT SHE HAD VISITED HER DOCTOR IN NOVEMBER AND THE EMERGENCY ROOM IN DECEMBER AND WAS DIAGNOSED WITH A URINARY TRACT INFECTION. SHE STATED SHE WAS PRESCRIBED ANTIBIOTICS BY HER DOCTOR FOR TREATMENT OF UTI. SHE ALSO STATED THAT SHE HAS EXPERIENCED RECURRING CASES OF BACTERIAL VAGINOSIS SINCE (B)(6) AND SUFFERED TWO MISCARRIAGES. MOST RECENTLY SHE SPENT A NIGHT IN THE ER IN (B)(6) WITH ANOTHER UTI. SHE INDICATED THAT HER PHYSICIAN COULD NOT DETERMINE THE CAUSE OF HER MEDICAL ISSUES, BUT SHE FEELS THEY ARE DUE TO TAMPON USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116838 KOTEX NATURAL BALANCE TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL REGULAR AC225725X2201

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other