BEUDAMED
    FDA Adverse Event Summary report: N

    COOK, INC.

    MDR report key: 238357 · Received September 2, 1999

    Report

    Report Number
    1820334-1999-00088
    Date Received
    September 2, 1999
    Date of Event
    August 5, 1999
    Report Date
    August 20, 1999
    Manufacturer
    COOK, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT GETTING PERCUTANEOUS NEPHROSTOMY UNDER FLUOROSCOPY USING A GUIDE WIRE. WHEN ATTEMPTED TO REMOVE GUIDE WIRE IT BROKE AT THE SOLDER POINT, LEAVING ABOUT 2.5 INCHES IN THE PT'S KIDNEY. ATTEMPTS TO SNARE REMAINING WIRE WERE UNSUCCESSFUL. PT TO UNDERGO LAPAROSCOPIC SURGERY TO REMOVE REMAINING WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK, INC. MANDRILL GUIDE WIRE DQX COOK, INC. * 906481

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O