BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX COMP 20X15CM OS VERSION X1

    MDR report key: 1140273 · Received August 29, 2008

    Report

    Report Number
    9615742-2008-00028
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    June 19, 2008
    Report Date
    August 26, 2008
    Manufacturer
    TREVOUX - USS
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE PT HAD INFECTION IN THE AREA OF THE MESH, NO OTHER INFO PROVIDED. NO ALLERGIES REPORTED ON DOCUMENT FORMS, NO TREATMENT WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX COMP 20X15CM OS VERSION X1 NONE FTL TREVOUX - USS PHG00265

    Patients

    Seq Age Sex Outcome Treatment
    1 Other