BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOTEX NATURAL BALANCE

    MDR report key: 3112186 · Received May 14, 2013

    Report

    Report Number
    2381757-2013-00017
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. THE CONSUMER RETURNED SOME UNUSED SAMPLES ON (B)(6) 2013 AND EVALUATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT SHE WAS DIAGNOSED WITH TOXIC SHOCK SYNDROME (TSS) ON (B)(6) 2013 AFTER TAMPON USAGE. THE CONSUMER INDICATED THAT SHE INSERTED A TAMPON ON (B)(6) 2013 AND EXPERIENCED VOMITING, SEVERE CRAMPING, PAIN IN HER LEFT SIDE, DIFFICULTY WALKING AND STANDING AFTER ABOUT ONE HOUR OF USAGE. SHE ALSO STATED THAT SHE WAS CURRENTLY TAKING ANTIBIOTICS FOR BRONCHITIS. SHE CONTINUED TO EXPERIENCE THESE SYMPTOMS FOR A COUPLE OF DAYS AND VISITED HER PHYSICIAN ON (B)(6) 2013 AS A FOLLOW-UP FOR HER BRONCHITIS. HOWEVER, SHE DID NOT MENTION HER ONGOING SYMPTOMS. SEVERAL DAYS LATER, SHE DEVELOPED A SUNBURN-LIKE RASH ON HER FACE AND FACIAL SWELLING UNDER HER EYES. SHE REVISITED HER PHYSICIAN AND WAS DIAGNOSED WITH A "MILD CASE" OF TSS. HER PHYSICIAN GAVE HER AN INJECTION OF ANTIBIOTICS. THE CONSUMER INDICATED THAT HER SYMPTOMS PERSISTED AND SHE VISITED THE EMERGENCY ROOM ON (B)(6) 2013. THE EMERGENCY ROOM PHYSICIAN PERFORMED SEVERAL TEST AND SENT HER HOME WITH CEPHALEXIN AND PAIN MEDICATION. SHE REVISITED HER DOCTOR ON (B)(6) 2013 FOR A FOLLOW-UP AND SHE RECEIVED ANOTHER ANTIBIOTIC INJECTION AND WAS PRESCRIBED CLINDAMYCIN. SHE EXPERIENCED AN ALLERGIC REACTION TO THIS MEDICATION, SO HER PHYSICIAN INSTRUCTED HER TO TAKE BENADRYL WITH HER ORAL ANTIBIOTICS. SHE INDICATED THAT SHE IS EXPERIENCING SORENESS AND STIFFNESS, AND THE SKIN ON HER KNUCKLES IS DRY AND CRACKING. SHE ALSO INDICATED THAT SHE IS EXPERIENCING AN ALLERGIC REACTION TO THE ANTIBIOTICS WHICH IS CAUSING HER TO BREAK OUT IN HIVES. DURING HER LAST VISIT ON (B)(6) 2013, SHE RECEIVED ANOTHER INJECTION OF ORAL ANTIBIOTICS AND ANOTHER PRESCRIPTION FOR ANTIBIOTICS. SHE IS CURRENTLY VISITING HER PHYSICIAN WEEKLY TO FOLLOW-UP ON HER SYMPTOMS. SHE INDICATED THAT HER PHYSICIAN IS REQUIRING HER TO RETURN TO THE OFFICE FOR WEEKLY-CHECKUPS IN LIEU OF HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212267 KOTEX NATURAL BALANCE TAMPON HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL REGULAR AC305625X1416

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other