BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR MESH

    MDR report key: 2967160 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00185
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    June 5, 2012
    Report Date
    June 5, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY FOR THIS LOT OF C-QUR MESH WAS REVIEWED AND NO DEVIATIONS IN THE MANUFACTURING OR STERILIZATION PROCESSES WERE NOTED. THE LOT HISTORY OF THE PROLITE MESH USED TO MANUFACTURE THIS LOT OF C-QUR WAS REVIEWED AND THE MECHANICAL STRENGTH PROPERTIES (BALL BURST AND SUTURE RETENTION STRENGTH) WERE WITHIN ATRIUM SPECIFICATIONS. PERMANENT TACKS ARE CAPABLE OF TEARING THROUGH THE POLYPROPYLENE MONOFILAMENTS IF THE COUNTER FORCES APPLIED DURING TACKING ARE OVERLY HIGH, OR IF THE TACKS ARE PLACED NEAR THE OUTSIDE EDGE OF THE MESH. FIXATION AWAY FROM THE EDGE OF THE MESH IS RECOMMENDED DURING SURGICAL PROCEDURE. WITHOUT BEING ABLE TO EVALUATE THE 6"X 8" C-QUR MESH THAT IS IN QUESTION, A DEFINITIVE CAUSE FOR THE PROTACKS GOING THROUGH THE C-QUR MESH DURING FIXATION COULD NOT BE DETERMINED. HOWEVER, A THOROUGH REVIEW OF THE LOT HISTORY OF THE MESH, INCLUDING THE MECHANICAL TESTING RESULTS OF THE BARE MESH ITSELF, INDICATED THAT THERE ARE NO REASONS TO CONCLUDE THAT THE C-QUR MESH WAS THE ROOT CAUSE OF THE DIFFICULTIES NOTED DURING THIS PROCEDURE.

    Description of Event or Problem · 1

    PROTACKS WERE GOING THROUGH THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621 C-QUR MESH FTL ATRIUM MEDICAL CORP. 31533 10740254

    Patients

    Seq Age Sex Outcome Treatment
    1 PERMENANT TACKS| PERMENENT SUTURES