BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMAGRAFT-TC

    MDR report key: 160670 · Received April 3, 1998

    Report

    Report Number
    2028403-1998-00005
    Event Type
    Injury
    Date Received
    April 3, 1998
    Date of Event
    May 6, 1997
    Report Date
    April 3, 1998
    Manufacturer
    ADVANCED TISSUE SCIENCES, INC.
    Product Code
    MGR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT PRESENTED WITH A 85-90% TBSA DEEP PARTIAL-THICKNESS/FULL-THICKNESS BURN. ON 5/6/1997, THE PT RECEIVED 26 PIECES OF DERMAGRAFT-TC (DGTC) (LOT 101182, 101183, 101184). THE DGTC WAS APPLIED OVER 4 TO 1 MESHED AUTOGRAFT. THE AUTOGRAFT HAD TO BE REMOVED DUE TO INFECTION. THE WOUND CULTURE WAS POSITIVE FOR PSEUDOMONAS AND STREPTOCOCCUS. ON 5/19/1997 THE SURGEON APPLIED ANOTHER 12 PIECES, LOT 1011852. THIS DGTC WAS APPLIED TO THE LEGS BUT HAD TO BE REMOVED DUE TO INFECTION, SOME ORGANISMS. ON 5/23/1997 16 PIECES WERE APPLIED, LOT 101226 AND 101228 AS A TEMPORARY COVERING AND OVER MESH AUTOGRAFT. THE AREA WAS INFECTED AND THE DGTC HAD TO BE REMOVED, CULTURES REVEALED SAME ORGANISM. INFECTION IS A COMMON COMPLICATION OF BURNS AND THERE IS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMAGRAFT-TC Implant HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE MGR ADVANCED TISSUE SCIENCES, INC. ZT 8000 101182-84,101185,101226,101228

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention