BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR EDGE

    MDR report key: 2963727 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00192
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    February 26, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAJORITY OF THE EDGE LAYER OF MESH AROUND THE PERIPHERY OF THE EXPLANT WAS IDENTIFIABLE AND STILL ATTACHED TO BASE LAYER OF MESH. NO TACKS OR SUTURES WERE FOUND IN THE PERIPHERY OR CENTER OF THE MESH EXPLANT. THE LOT HISTORY OF THE MESH WAS REVIEWED AND PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS. THE WRINKLING OF THE MESH DUE TO POOR FIXATION COULD HAVE CONTRIBUTED TO THE INCREASED FOREIGN BODY REACTION THAT COULD HAVE EXACERBATED THE SEROMA AND PREVENTED COMPLETE INCORPORATION OF THE MESH INTO THE ABDOMINAL WALL.

    Description of Event or Problem · 1

    MESH WAS EXPLANTED BECAUSE OF IMPROPER FIXATION AND BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030 C-QUR EDGE FTL ATRIUM MEDICAL CORP. 31234 10173425

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention