BEUDAMED
    FDA Adverse Event Injury Summary report: N

    READY-TO-STER. MICROTARGETING ELECTRODE KIT

    MDR report key: 691022 · Received March 21, 2006

    Report

    Report Number
    1226598-2006-00001
    Event Type
    Injury
    Date Received
    March 21, 2006
    Date of Event
    March 16, 2006
    Report Date
    March 16, 2006
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A NON-STERILE MER-4020T-NS KIT, INSTEAD OF THE STERILE MER-4020T, WAS INTRODUCED INTO A PT. THE CANNULA, STYLET, REDUCER INSERT AND MICROELECTRODE WERE ALL INTRODUCED INTO THE PT'S BRAIN DURING A DBS PROCEDURE. WHEN THIS WAS DISCOVERED, THE EQUIPMENT WAS REMOVED AND THE PROCEDURE WAS IMMEDIATELY ABORTED. DISTRIBUTOR REPRESENTATIVE REPORTED INITIALLY TO MANUFACTURER. REPRESENTATIVE ADVISED THAT THE -NS LABEL DOES STATE NON-STERILE BUT IT WAS NOT APPARANTLY IDENTIFIED AS SUCH BEFORE BEING INTRODUCED TO THE STERILE FIELD AND CLINICAL USE. ALL TESTS AS OF 3/2006 SHOW NO INFECTION OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 READY-TO-STER. MICROTARGETING ELECTRODE KIT GZL DEPTH ELECTRODE GZL FHC, INC. * 114788

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention