BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CQUR MESH

    MDR report key: 3763271 · Received April 10, 2014

    Report

    Report Number
    1219977-2014-00130
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING THE RETURN OF THE DEVICE AND ADD'L INFO IN ORDER TO PERFORM THE INVESTIGATION. A F/U REPORT SHALL BE SUBMITTED UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    THE PHYSICIAN IMPLANTED A MESH AND REPORTED THAT THE PT BEGAN HAVING PAIN THE NEXT DAY. THEY ADMITTED THE PT AND ATTEMPTED TO TREAT THE PAIN AND THEN RELEASED HIM. PT CAME BACK LESS THAN A WEEK LATER WITH SAME ISSUE AND THE MESH WAS EXPLANTED. THE PHYSICIAN NOTICED THAT BOWEL HAD ADHERED TO THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216189 CQUR MESH FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention