BEUDAMED
    FDA Adverse Event Other Summary report: N

    COOK INC

    MDR report key: 820605 · Received January 25, 2007

    Report

    Report Number
    820605
    Event Type
    Other
    Date Received
    January 25, 2007
    Date of Event
    June 30, 2006
    Report Date
    December 21, 2006
    Manufacturer
    COOK, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN FOR RENAL TRANSITIONAL CELL CARCINOMA AND BLADDER TRANSITIONAL CELL CARCINOMA WITH CYSTOSCOPY WITH TRANSURETHRAL RESECTION BLADDER TUMOR, BLADDER WASH, LEFT URETERAL CATHETERIZATION WITH RENAL PELVIS AND LEFT UNRETERAL WASHINGS FOR CYTOLOGY. COONS WIRE COATING CAME OFF WIRE DURING CEPHROSTOMY INSERTION. PARTS OF WIRE REMAINED IN NEPHROSTOMY TUBE. PHYSICIAN WILL HAVE PT COME BACK IN 2 WEEKS WHEN TRACT IS MATURE TO REINSERT NEW NEPHROSTOMY TUBE WITHOUT INSERTING WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK INC COONS WIRE DQX COOK, INC. THSF 38-80 F1892204

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other