BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITZMARKS

    MDR report key: 2081373 · Received April 28, 2011

    Report

    Report Number
    1119033-2011-00001
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 28, 2011
    Manufacturer
    KONSYL PHARMACEUTICALS, INC.
    Product Code
    FFX
    PMA / PMN Number
    K881609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER CLAIMS ALLERGIC RXN. IN USER. UNABLE TO DUPLICATE THIS RXN, WITH DEVICE IN LABORATORY TESTING.

    Description of Event or Problem · 1

    TOOK A SITZMARKS CAPSULE ON FRIDAY (B)(6) 2011, HAD UPSET STOMACH, VOMITED ONCE, AND WOKE UP ON SATURDAY (B)(6) 2011, BROKEN OUT IN A RED ITCHY RASH. WENT TO WORK AT RESTAURANT, AND WAS SENT HOME AT 11:30. WENT TO A GATHERING OF FRIENDS AT A NEARBY LODGE. HAD WORSENING HIVES AND ITCHING, TOOK 25MG BENADRYL, AND LATER ANOTHER 25MG. SUNDAY BROKEN OUT WORSE, AND ALMOST PASSED OUT. FRIENDS TOOK HER TO ER. WAS ADMITTED, TREATED WITH IV SOLUMEDROL 125MG AND IV AND PO BENADRYL. OTHER MEDS WERE TAKEN, BUT HAD BEEN ON ALL FOR A LONG TIME, EXCEPT FOR ALLOPURINOL 300MG THAT HAD BEEN RESTARTED ABOUT 9 DAYS BEFORE FOR ELEVATED URIC ACID (9.2) AND PAINFUL SWOLLEN 4TH RT TOE. NO PROBLEM WITH ALLOPURINOL PREVIOUS IN (B)(6) 2010. ALLERGIST, FRANK J. BLOCK, M.D. (270.217.2311) CONSULTED IN HER CARE; REPORTED THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITZMARKS RADIOPAQUE MARKERS FFX KONSYL PHARMACEUTICALS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization