BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR

    MDR report key: 2963682 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00218
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    February 9, 2012
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY OF THE MESH WAS REVIEWED AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THE COMPLAINT. SEROMA AND CELLULITIS ARE COMMON COMPLICATIONS THAT CAN OCCUR AFTER OPEN HERNIA REPAIR WITH ANY MESH. THE RISK COMPLICATIONS INCREASE IN PTS WITH COMORBID CONDITIONS SUCH AS LIVER TRANSPLANTATION.

    Description of Event or Problem · 1

    LATE ONSET PERI PROSTHETIC COLLATION AND ABDOMINAL WOUND CELLULITIS OCCURRED 3 MONTHS AFTER THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428 C-QUR FTL ATRIUM MEDICAL CORP 31542 10555005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSERTION OF A SURGICAL DRAINAGE TUBE WAS NEEDED