BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABS'AIR COMPOSITE

    MDR report key: 5238698 · Received November 12, 2015

    Report

    Report Number
    9616062-2015-00002
    Event Type
    Injury
    Date Received
    November 12, 2015
    Date of Event
    July 1, 2015
    Report Date
    October 31, 2015
    Manufacturer
    COUSIN BIOTECH
    Product Code
    FTL
    PMA / PMN Number
    K093196
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON CONFIRMED ONLY ONE PATIENT IS INVOLVED. DR. (B)(6) IMPLANTED A CABSAIR COMPOSITE DIAMETER 9 CM, AND HE IS FAMILIAR WITH THE SURGICAL TECHNIQUE AND PLACEMENT RECOMMENDATIONS. HE DID PLACE THE 4 RECOMMENDED SUTURES TO FIX THE DEVICE. THREE MONTHS AFTER THE IMPLANTATION OF THE DEVICE, THE PATIENT PRESENTED PAIN AROUND THE IMPLANT. DR (B)(6) DECIDED TO REOPERATE HIM. DURING THIS SECOND SURGERY, THE SURGEON FOUND SOME SOFT ADHESIONS THAT WERE EASY TO LIBERATE. THE IMPLANT WAS EXPLANTED AND THE DEFECT WAS CLOSED WITH SUTURES. REGARDING PATIENT'S SURGICAL HISTORY, DR (B)(6) EXPLAINED THAT THE PATIENT WAS VERY THIN (BMI 19) BUT MAINLY, HE HAD SURGERY FOR A COLONIC PERFORATION. DR (B)(6) AGREED THAT AN INTRAPERITONEAL DEVICE WAS PERHAPS NOT THE BEST SURGICAL CHOICE FOR THIS PATIENT AS IT IS KNOWN THAT PATIENTS WHO HAD BOWEL SURGERY ARE MORE LIKELY TO DEVELOP ADHESIONS. FROM THIS FIRST PHONE CALL WITH DR (B)(6), WE CAN ESTIMATE THAT THIS CASE OF SOFT ADHESIONS TO THE CABSAIR COMPOSITE DEVICE REMAINS A KNOWN COMPLICATION THAT IS WELL DESCRIBED IN THE LITERATURE REGARDING INTRAPERITONEAL MESHES. THE PATIENT WAS ALSO MORE SUSPECTABLE TO DEVELOP ADHESIONS BECAUSE OF HIS SURGICAL HISTORY.

    Description of Event or Problem · 1

    THIS EVENT HAS BEEN REPORTED TO COUSIN BIOTECH BY A (B)(6) DISTRIBUTOR. THE PATIENT UNDERWENT REPAIR OF A HERNIA WITH AN IMPLANT. AFTER A CERTAIN PERIOD OF TIME, THE PATIENT PRESENTED BOWEL ADHESIONS. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR THE REMOVAL OF CABSAIR COMPOSITE MESH. TODAY THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751556 CABS'AIR COMPOSITE CABS'AIR COMPOSITE FTL COUSIN BIOTECH CABSAIRC09 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention