BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITZMARKS

    MDR report key: 1355745 · Received April 2, 2009

    Report

    Report Number
    1119033-2009-00001
    Event Type
    Injury
    Date Received
    April 2, 2009
    Date of Event
    March 9, 2009
    Report Date
    March 10, 2009
    Manufacturer
    KONSYL PHARMACEUTICALS, INC.
    Product Code
    FFX
    PMA / PMN Number
    K881609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CLAIMS ALLERGIC RXN. UNABLE TO DUPLICATE THIS REXN. WITH DEVICE IN LABORATORY TESTING.

    Description of Event or Problem · 1

    TOOK SITZMARKS CAPSULE, APPROX 45-60 MIN. LATER SWELLING OF BOTTOM LIP, (WAS HAVING LUNCH AT BOB EVANS VEGETABLE SOUP & SALAD), AFTER 3 HRS WENT TO ER, CALLED DR. FOR SIDE EFFECTS OF CAPSULE, NON KNOWN, SWELLING IN CHIN, CHEEK THROAT FELT "FUNNY", ER PERSONNEL INDICATED BACK, RT. SIDE OF THROAT WAS SWELLING, ADMINISTERED IV (BENADRYL, STEROIDS), AFTER 2.5 HRS SWELLING SUBSIDING, LOOKED AT HANDS AND FINGERS WHICH WERE RED/PALMS WHITE; FEET AND TOES SIMILAR; SECOND ROUND OF IV & MEDS, RELEASED AT 7 P.M. INSTRUCTED TO TAKE BENADRYL EVERY 4-6 HOURS FOR 24 HRS. UNINTERRUPTED. PRESCRIPTION FOR MEDROL (STEROID PACK). RETURNED TO RESTAURANT TO FIND OUT WHAT WAS IN FOOD AND FOUND OUT THAT THE SOUP CONTAINED ANCHOVIES. PT HAS SHELLFISH ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITZMARKS RADIOPAQUE MARKERS FFX KONSYL PHARMACEUTICALS, INC. NA H82402

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other