BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMAGRAFT-TC

    MDR report key: 106184 · Received July 1, 1997

    Report

    Report Number
    106184
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    May 7, 1997
    Report Date
    June 30, 1997
    Manufacturer
    ADVANCED TISSUE SCIENCES
    Product Code
    MGR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT 1: ADMITTED 04/29/97; DISCHARGED 5/22/97. THIS PT HAD 45% FLAME BURNS. PT WENT TO SURGERY TO SURGERY 5/1 AND HAD DERMAGRAFT-TC (DG) APPLIED (LOT #101128 TO BACK, LOT #101184 TO BACK, CHEST). ON 5/7, NURSING NOTED PURULENT DRAINAGE BENEATH DG ON LEFT FLANK. TISSUE CULTURE OF SITE ON 5/8 GREW PSEUDOMONAS AERUGINOSA (PA); BLOOD CULTURE SAME DATE WAS NEGATIVE. PT WENT TO SURGERY 5/9 WITH A DIAGNOSIS OF INVASIVE PURULENT SEPSIS FOR DEBRIDEMENT OF THE DG. SIX OTHER PIECES OF DG ON THE PT'S BACK WERE FINE AND LASTED 21 DAYS.

    Description of Event or Problem · 2

    PT2: ADMITTED 5/18/97; DISCHARGED 6/20/97. THIS PT HAD 28% FLAME BURNS. PT WENT TO SURGERY 5/22 AND HAD DG APPLIED (LOT #101347 TO ANTERIOR CHEST, ARMS AND LOT #101232 TO ANTERIOR CHEST, ARMS). ON 5/25, SURGERY NOTED IN THE CHART, "40% LOSS OF DG, GREEN DRAINAGE, LOOKS LIKE PSEUDOMONAS". TISSUE CULTURE OF 5/25 GREW PA, RESPIRATORY CULTURE OF 5/24 GREW RARE PA. IN TOTAL, AP RECEIVED 10 PIECES OF DG AND WERE LOST, BUT 5 WERE FINE. DURING INVESTIGATION OF THESE TWO CASES, NO MORE PLAUSIBLE REASON FOR THE PSEUDOMONAS INFECTIONS WAS UNCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMAGRAFT-TC Implant HUMAN FIBROBLAST-DERIVED TEMPORARY SUBSTITUTE SKIN MGR ADVANCED TISSUE SCIENCES NA 1:101128,101184 2:101347(MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention
    2 9 YR Required Intervention