BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPOT

    MDR report key: 879793 · Received July 10, 2007

    Report

    Report Number
    2529592-2007-00002
    Event Type
    Other
    Date Received
    July 10, 2007
    Date of Event
    June 3, 2007
    Report Date
    June 25, 2007
    Manufacturer
    GI SUPPLY
    Product Code
    KOG
    PMA / PMN Number
    K993951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR MEDICAL DIRECTOR, WAS IN CONTACT WITH ANOTHER DR. EXACT PRODUCT WAS NOT AVAILABLE, HOWEVER, REMAINING PRODUCT FROM PACKAGE WAS RETURNED AND EVALUATED AGAINST OUR LONG TERM SAMPLES. TEST RESULTS SHOWED ALL PRODUCT TO BE STERILE AND PYROGEN FREE. FOLLOWO-UP E-MAILED REPORT FROM PT PHYSICIAN, DR ATTACHED. THE PT WAS DISCHARGED SEVERAL DAYS AGO WITH NO KNOWN DIAGNOSIS. SHE NORMALIZED AND WAS BACK TO NORMAL HEALTH. EVERYONE INVOLVED IN HER CARE FEEL WE WILL NEVER KNOW WHAT HAPPENED, BUT THE CONSENSUS IS THAT IT SEEMS VERY UNLIKELY RELATED TO THE ENDOSPOT.

    Description of Event or Problem · 1

    PT HAD SPOT INJECTED IN THE HEPATIC FLEXURE DURING ENDOSCOPIC PROCEDURE. FACILITY SUSPECTED "REACTION" TO SPOT WHEN PT HAVING ABDOMINAL DISCOMFORT IN 2007, AND FEVER OF UNK ORIGIN AND ABNORMAL LIVER FUNCTION ON THE NEXT DAY. A POST PROCEDURE LAPAROSCOPY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPOT ENDOSCOPIC COLON MARKER KOG GI SUPPLY GIS-44 021207

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization