BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 -04

    MDR report key: 1568977 · Received December 29, 2009

    Report

    Report Number
    3005473391-2009-00010
    Event Type
    Injury
    Date Received
    December 29, 2009
    Date of Event
    December 2, 2009
    Report Date
    December 9, 2009
    Manufacturer
    REDMOND
    Product Code
    ODE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER THEORIZED THAT A SMALL PINHOLE MAY HAVE INITIALLY BEEN PRESENT, BUT HAD CLOSED BY THE TIME THE UPPER GI WAS PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER SPOKE WITH THE COMPANY'S CHIEF MEDICAL OFFICER AND REPORTED THAT ONE OR TWO DAYS AFTER A SUCCESSFUL PROCEDURE TO REBUILD THE GEJ VALVE, THE PT WAS HAVING SOME DISCOMFORT. AN UPPER GI WAS PERFORMED AND NO LEAKS WERE SEEN, BUT MEDIASTINITUS WAS DIAGNOSED. ANTIBIOTICS WERE ADMINISTERED. THE PT CONTINUES TO RECOVER...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 -04 ODE REDMOND NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R