BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLASSIC DOUBLE PIGTAIL HC COATED URETERAL STENT

    MDR report key: 2110906 · Received March 18, 2011

    Report

    Report Number
    3005975494-2011-00004
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 18, 2011
    Manufacturer
    GYRUS ACMI L.P.
    Product Code
    FAD
    PMA / PMN Number
    K781641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISCARDED BY THE FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY. THE COMPLAINT WILL BE LOGGED INTO THE SYSTEM FOR TRENDING PURPOSES. A REVIEW OF THE DEVICE BUILD RECORDS INDICATES THAT THERE ARE NO DISCREPANCIES NOTED IN THE BUILD RECORDS FOR THIS LOT.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, WHILE PLACING A DOUBLE J STENT, THE STENT BROKE INTO TWO PIECES IN THE PT. THE PIECES WERE RETRIEVED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLASSIC DOUBLE PIGTAIL HC COATED URETERAL STENT DOUBLE J STENT FAD GYRUS ACMI L.P. 5202600 MCJW420

    Patients

    Seq Age Sex Outcome Treatment
    1