BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX COMP 3D PY 25X20CM NO THRX1

    MDR report key: 1140276 · Received August 29, 2008

    Report

    Report Number
    9615742-2008-00027
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    TREVOUX - USS
    Product Code
    FTL
    PMA / PMN Number
    K040998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE PT CONTACTED DOCTORS AFTER THE SECOND OPERATION REPAIR. AND STATED THAT THE HERNIA HAD RETURNED, DIAGNOSTIC WAS DETERMINED THAT MAYBE A PROBLEM WITH THE MESH. DOCTOR PERFORMED OPERATION ON PT IN '08 AND DISCOVERED THE MESH WAS ATTACHED AT THE FIXATION POINT, BUT HAD TORN THE LENGTH OF THE MESH. TISSUE DAMAGE WAS REPORTED, THE SURGEON USED ONE LAYER OF PERMACOL AND LAYERED TO SHEETS OF POLY PROPELENE MESH OVER THE PERMACOL, AND COMPLETED THE PREPERITONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX COMP 3D PY 25X20CM NO THRX1 SURGICAL MESH FTL TREVOUX - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other