BEUDAMED
    FDA Adverse Event Death Summary report: N

    C-QUR MESH

    MDR report key: 7455871 · Received April 24, 2018

    Report

    Report Number
    3011175548-2018-00398
    Event Type
    Death
    Date Received
    April 24, 2018
    Report Date
    April 24, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT NUMBER, LOT NUMBER OR SAMPLE WAS PROVIDED. PER THE ARTICLE, THE LONG-TERM EFFECTS OF MESHES WITH ANTI-ADHESIVE BARRIER ARE UNKNOWN. IT SHOULD BE NOTED THAT THESE MESHES HAVE THE POTENTIAL TO CAUSE MORBIDITY, SERIOUS HEALTH PROBLEMS OR EVEN DEATH.

    Description of Event or Problem · 1

    ARTICLE RECEIVED TITLED "OMEGA-3 FATTY ACID COVERED POLYPROPYLENE MESH FOR ABDOMINAL WALL HERNIA REPAIR: A PROSPECTIVE ANALYSIS OF 30 PATIENTS". THE ARTICLE ANALYZES POSTOPERATIVE OUTCOMES IN PATIENTS OPERATED WITH OMEGA-3 FATTY ACID COVERED POLYPROPYLENE MESH FOR ABDOMINAL WALL HERNIA REPAIR. PER THE ARTICLE, ONE PATIENT EXPIRED 5 MONTHS AFTER THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298040 C-QUR MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention