BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 2175651 · Received July 19, 2011

    Report

    Report Number
    3005473391-2011-00039
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 18, 2011
    Manufacturer
    REDMOND
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE IT HAD ALREADY BEEN DISPOSED PER THE HOSPITAL'S STANDARD OPERATING PROCEDURES.

    Description of Event or Problem · 1

    WHILE PERFORMING A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, A MICRO PERFORATION OCCURRED. THE PT WAS ADMINISTERED IV ANTIBIOTICS, AND NPO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 - LINK DESIGN - SHORT ODE REDMOND R2002 400911

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R