BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1936046 · Received December 13, 2010

    Report

    Report Number
    9680809-2010-00003
    Event Type
    Injury
    Date Received
    December 13, 2010
    Product Code
    FCG
    PMA / PMN Number
    K070129
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6) AND WAS REPORTED TO OUR PRIVATE LABEL DISTRIBUTOR OF THIS PRODUCT WHICH WAS THEN REPORTED TO OUR MANUFACTURING FACILITY IN (B)(4). AS THE DEVICE INVOLVED IN THIS EVENT WAS DESTROYED, MEDI-GLOBE, (B)(4) IS WAITING TO RECEIVE A DIFFERENT DEVICE FROM THE SAME MANUFACTURING LOT IN ORDER TO CONDUCT DEVICE TESTING. MEDI-GLOBE (B)(4) IS THE MFR OF THE DEVICE AND SUPPLIES A PRIVATELY LABELED VERSION OF THIS DEVICE TO CONMED CORPORATION WHO IS AN AUTHORIZED DISTRIBUTOR OF MEDI-GLOBE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A PROCEDURE FOR FINE NEEDLE ASPIRATION OF A PANCREATIC LESION. THE PATIENT DEVELOPED ACUTE PANCREATITIS AFTER AN ULTRASOUND GUIDED FINE NEEDLE ASPIRATION PROCEDURE USING THE MEDI-GLOBE EUS GUIDED FNA NEEDLE. AFTER THE CYTOLOGY LAB RECEIVED THE SPECIMEN FROM THE PROCEDURE, IT WAS NOTED THAT THERE WAS SOME MICROSCOPIC PARTICLES IN THE THIN PREP MATERIAL OF THE ISTHMUS AREA. THE CYTOLOGIST FELT THAT THE PARTICLES MAY HAVE BEEN METALLIC FILINGS. SUBSEQUENT FINDINGS IN THE LIQUID PHASE CYTOLOGY AS WELL AS THREE ADDITIONAL SAMPLES WERE ALSO CONSISTENT. THE PATIENT REMAINED IN THE HOSPITAL FOR CONTINUED MEDICAL CARE FOR APPROXIMATELY ONE MONTH BEFORE BEING DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE NONE FCG

    Patients

    Seq Age Sex Outcome Treatment
    1