BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U BY KOTEX CLICK

    MDR report key: 6979247 · Received October 26, 2017

    Report

    Report Number
    3011109575-2017-00083
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    October 1, 2017
    Manufacturer
    K-C AFC MANUFACTURING, S. DE. R.L. DE C.V.
    Product Code
    HEB
    UDI-DI
    00036000998412
    PMA / PMN Number
    K113036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) AND QUALITY RECORDS WERE REVIEWED. THESE DOCUMENTS DEMONSTRATE THAT PROCEDURES WERE CORRECTLY FOLLOWED. NO OTHER SIMILAR OR RELATED COMPLAINTS FOR THE REPORTED LOT WERE FOUND. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A REGULAR BASIS OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. IN ADDITION, COMPLAINTS ARE ALSO MONITORED FOR TRENDING ON A MONTHLY CADENCE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT SHE HAS BEEN USING KOTEX FOR ABOUT A YEAR. ON (B)(6) 2017, WHILE WEARING A TAMPON SHE EXPERIENCED DIZZINESS, VOMITING, CHILLS, SHAKES, SWEATS AND SHARP ABDOMINAL PAIN AND SIDE PAIN. SHE STATED SHE WAS UNABLE TO EAT OR DRINK DUE TO NAUSEA AND HAD A FEVER OF 101.0 F. SHE WENT TO THE ER. A VAGINAL EXAM WAS PERFORMED AND NO PIECES OF THE TAMPON WERE FOUND INSIDE. BLOOD WORK WAS OBTAINED; WHEREUPON, SHE WAS DIAGNOSED WITH TOXIC SHOCK SYNDROME (TSS). SHE WAS GIVEN ORAL ANTIBIOTICS AND WAS SENT HOME TO RECOVER. SHE SCHEDULED A FOLLOW-UP WITH HER PCP. SHE STATED THERE WERE NO PROBLEMS WITH THE TAMPON ITSELF INDICATING IT LOOKED NORMAL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760883 U BY KOTEX CLICK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE. R.L. DE C.V. SUPER PLUS NN717313A1533 00036000998412

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other