BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOF-FLEX DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 1941475 · Received December 14, 2010

    Report

    Report Number
    1941475
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 14, 2010
    Manufacturer
    COOK
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING A STENT IN THE PT'S URETER, A METAL RING ON THE STENT PUSHER BROKE OFF IN THE PT. A CYSTOSCOPY WAS PERFORMED AND AN INTRA-OPERATIVE FLUOROSCOPY WAS USED TO LOCATE THE SMALL RING. THE RING WAS APPROXIMATELY FIVE MM IN SIZE. A GRASPER WAS PASSED INTO THE BLADDER AND THE RING WAS CAPTURED. THE PATIENT WAS NOT HARMED. THIS WAS A DEFECTIVE PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF-FLEX DOUBLE PIGTAIL URETERAL STENT SET URETERAL STENT SET FAD COOK G14956 U1886711

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR