BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITZMARKS

    MDR report key: 2086445 · Received May 4, 2011

    Report

    Report Number
    1119033-2011-00002
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 3, 2011
    Manufacturer
    KONSYL PHARMACEUTICALS, INC.
    Product Code
    FFX
    PMA / PMN Number
    K881609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER CLAIMS ANAPHYLACTIC RXN. IN SELF. UNABLE TO DUPLICATE THIS RXN. WITH DEVICE IN LABORATORY TESTING.

    Description of Event or Problem · 1

    GASTROENTEROLOGIST GAVE PILL FOR A (B)(4) STUDY. REACTS SEVERELY TO SULFA DRUGS IN THE PAST, FEELS HE SHOULD HAVE KNOWN NOT TO GIVE PILL. HAD AN ANAPHYLACTIC REACTION. (SITZMARKS CONTAINS BARIUM SULPHATE).

    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 UNK Hospitalization