BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 -05

    MDR report key: 2023561 · Received March 16, 2011

    Report

    Report Number
    3005473391-2011-00033
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 14, 2011
    Manufacturer
    REDMOND
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: BECAUSE THE ADVERSE PATIENT SYMPTOMS PRESENTED ITSELF AFTER DISCHARGING THE PATIENT, THE DEVICE HAD ALREADY BEEN DISPOSED OF PER THE HOSPITAL'S STANDARD OPERATING PROCEDURE AND IS NOT AVAILABLE FOR EVALUATION. THE PATIENT IS STILL RECOVERING.

    Description of Event or Problem · 1

    AFTER A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND LATER THAT NIGHT COMPLAINED OF CHEST PAIN AND COUGHING. THE PATIENT WAS READMITTED. DURING A CT SCAN, A LEFT PLEURAL EFFUSION WAS SEEN ALONG WITH AIR IN THE LEFT MEDIASTINUM. DURING A BARIUM SWALLOW STUDY, A 3 MM TEAR WAS OBSERVED APPROXIMATELY 2 CM ABOVE THE GE JUNCTION. THE PHYSICIAN PLACED A CHEST TUBE TO HELP DRAIN THE PLEURAL FLUID AND SENT THE PATIENT TO ANOTHER HOSPITAL FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 -05 ODE REDMOND R2000 400770

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R