BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISIS BIODESIGN COMPLEX HERNIA GRAFT

    MDR report key: 1151305 · Received September 4, 2008

    Report

    Report Number
    1835959-2008-00003
    Event Type
    Injury
    Date Received
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    COOK BIOTECH INC.
    Product Code
    GXQ
    PMA / PMN Number
    K031850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE RETURNED FOR EXAMINATION. MANUFACTURER BELIEVES THAT A 15 CM WIDE DEFECT IS TOO WIDE FOR A 20 CM DEVICE TO BRIDGE AND ALLOW 5 CM OVERLAP ON EACH SIDE AS PER DFU. PT WAS UNLIKELY TO BE ABLE TO LAY DOWN SIGNIFICANT NEW COLLAGEN AND ANGIOGENESIS TO ENABLE REMODELING BEFORE THE HIGH LEVEL OF CONTAMINATION DEGRADED THE GRAFT.

    Description of Event or Problem · 1

    DR USED SURGISIS BIODESIGN COMPLEX HERNIA GRAFT FOR A VERY DIFFICULT, CHALLENGING CASE INVOLVING AN OBESE FEMALE PT REQUIRING EMERGENCY SURGERY FOR GANGRENOUS SMALL BOWEL AND COLON BECAUSE OF BOWEL INCARCERATED IN A LARGE VENTRAL HERNIA. SMALL BOWEL AND COLON WERE RESECTED AND A TEMPORARY ILEOSTOMY WAS CREATED. PT HAS HAD MULTIPLE PRIOR ABDOMINAL OPERATIONS. HE COULD NOT CLOSE THE ABDOMINAL FASCIA AND SPANNED OVER 10-15 CM WITH SURGISIS, SUTURED WELL WITH GOOD OVERLAP. DRAINS IN PLACE. ABOUT 10-12 DAYS POST OPERATIVE, THE SKIN SEPARATED AND BOWEL PROTRUDED. AT OPERATION, THE MESH WAS MOSTLY GONE. HE THOUGHT THERE WAS PUS, BUT CAN'T REMEMBER IF HE CULTURED OR NOT. HE CLEANED UP THE WOUND AND USED ALLODERM TO RECLOSE. THIS WOULD CONSIDERED A CONTAMINATED WOUND AFTER COLON RESECTION WITH DEAD BOWEL. PT IS HOME SLOWLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISIS BIODESIGN COMPLEX HERNIA GRAFT SURGICAL MESH 21CFR PART 882.5910 (GXQ) GXQ COOK BIOTECH INC. G48216 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE KNOWN