BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMWD 4X5, SINGLE

    MDR report key: 955125 · Received November 29, 2007

    Report

    Report Number
    1121308-2007-00017
    Event Type
    Injury
    Date Received
    November 29, 2007
    Date of Event
    October 21, 2007
    Report Date
    November 29, 2007
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS A COLLAGEN BASED MATERIAL DESIGNED TO RESORB INTO THE BODY. THE MATERIAL DEGRADATION WOULD NOT ALLOW FOR THE DEVICE TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED, THE FOLLOWING INCIDENT: A WOMAN HAD A LARGE STAGE III DECUBITUS ULCER ON HER LEFT LEG. THE PATIENT WAS ADMITTED IN 2007, TO THE HOSPITAL WITH A GRAM POSITIVE COCCI INFECTION, STAPH AUREUS, AND MRSA NEGATIVE. THE BLOOD CULTURES WERE POSITIVE AND INCREASED WHITE BLOOD CELL COUNT. THE PATIENT WAS DEBRIDED ON THE SAME DAY AND LAVAGED WITH BACITRACIN AND THEN PLACED ON IV FLUIDS WITH VANCOMYCIN AND THEN LEVOQUIN. THE PHYSICIAN KNEW OF SYSTEMIC INFECTION AND TRIED TO ERADICATE PRIOR TO PLACEMENT OF BMWD TO PREVENT AMPUTATION OF THE LEG. THE PATIENT WAS DEBRIDED EXTENSIVELY THE NEXT MONTH WITH INSTRUMENT AND WITH ASPIRATING WATER (POSSIBLE SOURCE OF NEW INFECTION). MWD WAS USED TO FILL THE VOID IN THE LEG AND THEN PLACED BMWD ON THE TOP. TWELVE DAYS LATER, EXUDATE WAS NOTICED WHEN THE DRESSINGS WERE CHANGED AND A SAMPLE WAS SENT OUT FOR CULTURE AND IDENTIFICATION; BLOOD CULTURES AND URINALYSIS NEGATIVE. THE PATIENT WAS PLACED ON BACTRIM/SEPTRA. FOUR DAYS LATER, THE PHYSICIAN NOTICED NO INFECTION ON THE WOUND BED, BUT THE BMWD DID NOT TAKE DUE TO THE INFECTION. THE NEXT DAY, THE PHYSICIAN REMOVED WHAT WAS LEFT OF THE GRAFT. THREE DAYS LATER, THE RESULTS OF THE TESTS RECEIVED THE LABORATORY'S IDENTIFICATION OF THE ORGANISM AS STENOTROPHOMONAS MALTOPHILIA, A GRAM NEGATIVE BACILLUS FOUND IN SOIL, WATER, URINE, RESPIRATORY INFECTIONS. THE POST-OPERATIVE INFECTION WAS DIFFERENT FROM INITIAL INFECTION OF GRAM POSITIVE COCCI. A WOUND VAC WAS PLACED ON THE PATIENT'S LEG. THE NEXT DAY, ANOTHER SAMPLE WAS SUBMITTED FROM THE SITE FOR CULTURE. THE PHYSICIAN HOPES THAT THE SITE IS FREE OF INFECTION AND WILL RE-APPLY BMWD AND MWD. THIS INCIDENT IS RELATED TO MDR NUMBER 1121308-2007-00016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMWD 4X5, SINGLE INTEGRA WOUND DRESSING FRO INTEGRA LIFESCIENCES 105BA0091221

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention LEVOQUIN| VANCOMYCIN| BILAYER MATRIX WOUND DRESSING (INTEGRA)