BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISIS BIODESIGN COMPLEX HERNIA GRAFT

    MDR report key: 1163608 · Received September 17, 2008

    Report

    Report Number
    1835959-2008-00004
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    July 25, 2008
    Report Date
    September 17, 2008
    Manufacturer
    COOK BIOTECH INC.
    Product Code
    GXQ
    PMA / PMN Number
    K031850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE RETURNED FOR EXAMINATION. MANUFACTURER BELIEVES THAT A MRSA INFECTION MAY HAVE CONTRIBUTED TO DEGRADATION OF THE GRAFT. 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. ON AUGUST 18, 2008, SALES MANAGER NOTIFIED COOK BIOTECH INC. OF THIS COMPLAINT. WE WERE UNABLE TO COMMUNICATE WITH A DR. OUR CONSULTING SURGEON CONTACTED HIS OFFICE 15 TIMES VIA TELEPHONE AND EMAIL WITH NO SUCCESS. BECAUSE OF THIS, WE HAVE RECEIVED VERY FEW DETAILS CONCERNING THIS EVENT, HOWEVER, WE THOUGHT IT TO BE PRUDENT TO FILE THIS REPORT.

    Description of Event or Problem · 1

    A BARIATRIC SURGEON, TREATED A OBESE, DIABETIC PT WHO HAD AN INFECTED MESH. HE REMOVED ALL OF THE INFECTED MESH, PLACED SURGISIS BIODESIGN COMPLEX HERNIA GRAFT, AS AN UNDERLAY WITH A 5 CM OVERLAP. HE CULTURED THE WOUND AND IDENTIFIED A FORM OF MRSA. A WEEK LATER, THE GRAFT HAD DEGRADED AND THE BOWEL PROTRUDED THRU THE GRAFT.

    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