BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITZMARKS

    MDR report key: 1618182 · Received February 25, 2010

    Report

    Report Number
    1119033-2010-00001
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    January 24, 2010
    Report Date
    February 23, 2010
    Manufacturer
    KONSYL PHARMACEUTICALS, INC.
    Product Code
    FFX
    PMA / PMN Number
    K881609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TOOK SITZMARKS CAPSULE ON SUNDAY, JAN 24TH; MONDAY HAD A RASH ON CHEST AND RIGHT HIP. STARTED USING BENADRYL LOTION AND CAPSULES. RASH CONTINUED TO APPEAR MOVING AROUND GROIN AREA; PRESENTED MORE ON THE RIGHT SIDE THAN ON THE LEFT. WAITED 5 DAYS AND WENT IN FOR X-RAY (SITZMARKS PROTOCOL). ALL MARKERS PRESENT AND HIGH IN BOWEL. AFTER 5 MORE DAYS, 13 MARKERS LEFT. A DEFECOGRAPHY TEST WAS ORDERED AND MORE BARIUM ADMINISTERED. RASHES GOT WORSE; NAUSEA AND HEADACHE. SURGEONS OFFICE SUGGESTED SENNOKOT AND STOOL SOFTENERS TO FLUSH PRODUCTS OUT OF SYSTEM. WILL FOLLOW-UP WITH SURGEON FRIDAY, FEB 26TH. WHEN ASKED IF A PHYSICIAN HAD BEEN SEEN SINCE ONSET OF THE RASH AND SYMPTOMS, PT WAS EVASIVE AND UNCLEAR. WHEN PT MADE INITIAL CONTACT WITH CUSTOMER SERVICE AT (B) (4) PHARMACEUTICALS, SHE WAS SENT A LISTING OF ALL INGREDIENTS IN THE SITZMARKS DEVICE.

    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 Other