BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK UNIVERSAL URETERAL STENT

    MDR report key: 3324811 · Received August 29, 2013

    Report

    Report Number
    MW5031679
    Event Type
    Injury
    Date Received
    August 29, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 28, 2013
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS UNABLE TO REMOVE A LEFT URETERAL STENT IN HIS OFFICE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR STENT REMOVAL. THE PIGTAIL PORTION OF THE STENT WAS ENCRUSTED WITH CALCIUM DEPOSITS AND DEBRIS. THE STENT WAS GRASPED WITH GRASPING FORCEPS AND GENTLY REMOVED. THE MORE PROXIMAL PORTION OF THE STENT WAS TEMPORARILY HUNG UP IN THE DISTAL URETER BUT IT WAS REMOVED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424987 COOK UNIVERSAL URETERAL STENT URETERAL STENT FAD COOK UROLOGICAL, INC. G49898 U2283050

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention