BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERAL STENT

    MDR report key: 24844 · Received July 25, 1995

    Report

    Report Number
    24844
    Event Type
    Injury
    Date Received
    July 25, 1995
    Date of Event
    May 11, 1995
    Report Date
    May 25, 1995
    Manufacturer
    COOK UROLOGICAL
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CT PERFORMED DURING 2/12/95 ADMISSION SHOWED CHRONICALLY OBSTRUCTED LEFT KIDNEY & NEW ONSET OBSTRUCTION RIGHT KIDNEY. PLACEMENT OF DOUBLE J-STENT WAS ATTEMPTED. DIFFICULTY WAS ENCOUNTERED WITH THE 4.7 FR STENT INCLUDING "RELEASE OF THE BINDING" & "SPRINGING OFF THE END OF THE PUSHER & DISAPPEARING INTO THE INTRAMURAL URETER. A BASKET APPROACH TO RETRIEVE THIS WAS UNSUCCESSFUL. A NEW 6FR STENT WAS PLACED & THE 4.7 WAS REMOVED 5/11/95 IN INTERNATIONAL RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETERAL STENT Implant STENT FAD COOK UROLOGICAL 4.7 FRX 22-32CM A147634

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention COOK UROLOGICAL PLACED AT ORIGINAL DATE 2/12/95.| 6FR X 22-32CM LOT #A-189608 REORDER # 039600