BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KC-002

    MDR report key: 2894703 · Received June 13, 2008

    Report

    Report Number
    2894703
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 7, 2007
    Report Date
    May 8, 2008
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    GAO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBJECT (B)(6) INITIALLY RANDOMIZED INTO THE CONTROL GROUP FOR THE KC-002 TRIAL AND HAD THE BASELINE VISIT TO BEGIN CONTROL TREATMENT ON (B)(6) 2006. TARGET ULCER WAS LOCATED ON THE LEFT GREAT TOE. PER THE KC-002 PROTOCOL, IF A SUBJECT WHO WAS RANDOMIZED TO A CONTROL, DOES NOT ACHIEVE MORE THAN 50% OF CLOSURE OF THEIR TARGET ULCER FROM BASELINE TO THE END OF THE STUDY (24 WEEKS), THE SUBJECT CAN CHOOSE TO RECEIVE THE KC-002 TREATMENT. SUBJECT (B)(6) WAS GRANTED AN EXCEPTION FROM THE MEDICAL MONITOR ON (B)(6) 2007 TO RE-ENTER THE TRIAL AND RECEIVE THE KC-002 DEVICE TREATMENT. THE SUBJECT COMPLETED THE 12-WEEK TREATMENT PHASE WITHOUT INCIDENT. WHEN THE SUBJECT WAS EXPECTED FOR THE F/U F6/WEEK 18 VISIT ON (B)(6) 2007, THE SITE WAS INFORMED THE SUBJECT WAS ADMITTED INTO THE HOSP WITH INFECTION OF THE TARGET ULCER. SYMPTOMS BEGAN ON (B)(6) 2007. ANTIBIOTICS WERE PRESCRIBED. CULTURE AND SENSITIVITY OF THE TARGET ULCER WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS AND AN MRI INDICATED OSTEOMYELITIS OF THE PROXIMAL PHALANX AND SEPTIC ARTHRITIS OF THE METACARPOPHALANGEAL JOINT. AMPUTATION OF THE LEFT HALLUX WAS PERFORMED ON (B)(6) 2007 DUE TO OSTEOMYELITIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2007. AS OF (B)(6) 2007, THE INCISION IS COMPLETELY HEALED WITH NO SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KC-002 GAO GENZYME BIOSURGERY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R