BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 1871043 · Received October 8, 2010

    Report

    Report Number
    1825146-2010-00046
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    August 27, 2010
    Report Date
    October 8, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL AT THIS TIME. INFO RECEIVED INDICATES THE STENT SEGMENTS WERE REMOVED USING GRASPING FORCEPS WITHIN THE SAME PROCEDURE AND ANOTHER STENT PLACED. UPON RECEIPT OF THE DEVICE AND ADDITIONAL INFO A FOLLOW UP REPORT WILL BE COMPLETED.

    Description of Event or Problem · 1

    A STENT WAS REMOVED IN THREE PIECES FROM A STONE PT. A NEW STENT WAS PLACED. STENT REMOVED FROM THE PT IN THREE PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF-FLEX DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK UROLOGICAL, INC. NA U1646242

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention