BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR

    MDR report key: 2963702 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00202
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    March 21, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ATRIUM FOR EVAL, BUT THE LOT HISTORY RECORD OF THIS LOT OF MESH WAS EXAMINED AND NO DEVIATIONS WERE NOTED. A DEFINITIVE CAUSE OF THE ASCITES IN THIS CASE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED; HOWEVER, THERE ARE NO REASONS TO SUSPECT THAT THE C-QUR MESH DEVICE ITSELF WAS THE ROOT CAUSE OF ASCITES FORMATION IN THIS CASE. THE COMPLAINT DID NOT MAKE CLEAR WHETHER OR NOT THE IMPLANT WAS REMOVED FROM THE PT. THERE ARE A NUMBER OF SURGICAL AND PT FACTORS WHICH COULD IMPACT THE CLINICAL MANIFESTATION OF ASCITES (FLUID BUILDUP IN THE ABDOMEN), ESPECIALLY IN COMPLICATED PTS SUCH AS THIS. ASCITES IS A KNOWN COMPLICATION OF GASTRIC CANCER (STOMACH CANCER) AND HAS ALSO BEEN REPORTED TO OCCUR AFTER SUBTOTAL GASTRECTOMY FOR TREATMENT OF GASTRIC CANCER (STOMACH CANCER).

    Description of Event or Problem · 1

    PT DEVELOPED BIG HERNIA 4 MONTHS AFTER MESH IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984 C-QUR FTL ATRIUM MEDICAL CORP. 31542 10552805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention