BEUDAMED
    FDA Adverse Event Summary report: N

    SILHOUETTE

    MDR report key: 2892043 · Received December 17, 2012

    Report

    Report Number
    2892043
    Date Received
    December 17, 2012
    Date of Event
    October 12, 2012
    Report Date
    December 17, 2012
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP
    Product Code
    FAD
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A URETERAL STENT SPONTANEOUSLY MIGRATED OUT OF THE URETER INTO THE BLADDER AND OUT THROUGH THE URETHRA OF THE PATIENT. TO DATE, NO NEW STENT HAS BEEN INSERTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE STENT, URETERAL FAD APPLIED MEDICAL RESOURCES CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR