BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY CORE

    MDR report key: 1103483 · Received August 7, 2008

    Report

    Report Number
    MW5007936
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    June 18, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    KIDNEY BIOPSY "EASY CORE" MALFUNCTION. THE 1ST DEVICE OPERATED CORRECT ONE TIME, 2ND TIME WHILE DEVICE INSIDE OF PT DID NOT OPERATE. THE 2ND DEVICE NEVER WORKED, AND 3RD DEVICE DID WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY CORE BIOPSY DEVICE KNW BOSTON SCIENTIFIC 500-104 9529169

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR