BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR

    MDR report key: 2963689 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00209
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    March 8, 2010
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACTERIAL CULTURE REPORT INDICATED THAT "CULTURES FROM ABDOMEN AND MESH BOTH GREW (B)(6). THE EXPLANTED MESH WAS NOT RETURNED TO ATRIUM FOR PHYSICAL EVALUATION AND NO PICTURES WERE TAKEN OF THE MESH AT EXPLANT. THE LOT HISTORY AND STERILIZATION RECORDS OF THIS LOT OF C-QUR MESH WERE REVIEWED AND NO DEVIATIONS WERE FOUND. POST-OPERATIVE INFECTION AFTER HERNIA REPAIR USING MESH IS A COMMON OCCURRENCE AND THE RATE OF INFECTION TENDS TO INCREASE IN PATIENTS WITH CONDITIONS SUCH AS DIABETES OR OBESITY. ACCORDING TO THE CASE REPORT THERE WAS MINIMAL TISSUE ATTACHMENT OR INGROWTH INTO THE MESH. THE PRESENCE OF A SIGNIFICANT INFECTION AND FLUID SURROUNDING THE MESH, REQUIRING MESH REMOVAL, MOST LIKELY LED TO THE LACK OF TISSUE INCORPORATION. WITHOUT ACCESSING THE PHYSICAL EXPLANT, PHOTOS OF THE EXPLANT OR PATIENT HISTORY, NO OTHER DETERMINATIONS CAN BE MADE.

    Description of Event or Problem · 1

    SURGICAL SITE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659 C-QUR FTL ATRIUM MEDICAL CORP. 31528 10513689

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention