BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR EDGE MESH

    MDR report key: 2963673 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00187
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    April 20, 2009
    Report Date
    April 22, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EXAMINATION, THE EXPLANT DID NOT APPEAR TO BE IMMERSED IN FORMALIN AND WAS ALMOST BLACK IN COLOR. FOR THIS REASON, THE PHYSICAL APPEARANCE OF THE EXPLANT WAS NOT INVESTIGATED THOROUGHLY. SINCE ATRIUM WAS UNABLE TO OBTAIN THE LOT NUMBER OF THE PRODUCT FROM THE HOSPITAL, THE LOT HISTORY RECORD OF THE MESH WAS NOT ABLE TO BE REVIEWED. SOFT TISSUE INFECTIONS LEADING TO MESH INFECTIONS ARE NOT INFREQUENT OCCURRENCES IN HERNIA REPAIR, ESPECIALLY OPEN ABDOMINAL REPAIR. (B)(4) REPORTS AN 8.7% WOUND INFECTION AFTER HERNIA SURGERY USING MESH. THE CAUSES OF THESE INFECTIONS ARE NUMEROUS BUT ARE MOSTLY RELATED TO SURGICAL TECHNIQUE AND PT HEALTH. WITH THE INFO AVAILABLE, WE WERE UNABLE TO DETERMINE A CAUSE OF INFECTION RESULTING IN THE NECESSITY OF MESH EXPLANT.

    Description of Event or Problem · 1

    INFECTED EXPLANT BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976 C-QUR EDGE MESH FTL ATRIUM MEDICAL CORP. 31228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention