BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU PATH BIOPSY NEEDLE

    MDR report key: 732655 · Received June 30, 2006

    Report

    Report Number
    6000043-2006-00079
    Event Type
    Injury
    Date Received
    June 30, 2006
    Date of Event
    June 13, 2006
    Report Date
    June 30, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECIFICATIONS. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT AT THIS TIME. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES.

    Description of Event or Problem · 1

    UPON COMPLETION OF A SUCCESSFUL PROSTATE BIOPSY PROCEDURE THAT OCCURRED IN 2006 DIFFICULTY OCCURRED WHEN ATTEMPTING TO RELEASE THE SPECIMEN. AFTER SEVERAL ATTEMPTS A PORTION OF THE SPECIMEN INADVERTENTLY FLEW ACROSS THE ROOM STRIKING AN EMPLOYEE ON THE UPPER LIP. NO INJURY WAS SUSTAINED. PRECAUTIONARY MEASURES WERE TAKEN WITH A HEPATITIS BOOSTER SHOT AND PERIODIC HIV TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU PATH BIOPSY NEEDLE BIOPSY DEVICE FCG BOSTON SCIENTIFIC 500-115 8136243

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention