BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z

    MDR report key: 9188920 · Received October 14, 2019

    Report

    Report Number
    3005473391-2019-00125
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    September 16, 2019
    Report Date
    October 14, 2019
    Product Code
    ODE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE PATIENT'S PERFORATION. THE PHYSICIAN SPECULATES THE PERFORATION WAS CAUSED BY TOO MANY SEROSAFUSE FASTENERS PLACED IN ONE LOCATION.

    Description of Event or Problem · 1

    A PATIENT WAS DIAGNOSED WITH A PERFORATION ON THEIR GEJ THE DAY AFTER A SUCCESSFUL TIF PROCEDURE. AN 18MM ESOPHAGEAL STENT WAS USED TO TREAT THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982296 ESOPHYX Z ODE ODE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention