BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCYTE

    MDR report key: 295021 · Received September 8, 2000

    Report

    Report Number
    2028403-2000-00009
    Event Type
    Injury
    Date Received
    September 8, 2000
    Date of Event
    July 28, 2000
    Report Date
    September 6, 2000
    Manufacturer
    ADVANCED TISSUE SCIENCES, INC.
    Product Code
    MGR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ENROLLED INTO STUDY PROTOCOL TC-01-07-0597 IN 2000. IN 2000, 11 CASSETTES OF TRANSCYTE WERE PLACED ON THE PT'S FULL THICKNESS BURNS. THE PT HAD SUSTAINED 60% TOTAL BODY SURFACE AREA BURNS IN 2000; 55% WERE FULL THICKNESS BURNS. IN 2000, EIGHT DAYS AFTER APPLICATION, STUDY PERSONNEL RECORDED THAT THERE WAS A PURULENCE UNDER A PORTION OF THE TRNSCYTE. APPROXIMATELY 1.5 CASSETTES WERE REMOVED FROM THE WOUNDS. A SWAB CULTURE REVEALED HEAVY GROWTH OF METHICILLIN-RESISTANT STAPHYLOCCUS AUREUS. THE INFECTION WAS TREATED WITH TOPICAL ANTIBIOTICS. THE INFECTION SUBSEQUENTLY RESOLVED. STUDY PERSONNEL DO NOT BELIEVE THAT TRANSCYTE CAUSED OR CONTRIBUTED TO THE OCCURRENCE OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSCYTE HUMAN FIBROBLAST DERIVED TOMPORARY SKIN SUBSTITUTE MGR ADVANCED TISSUE SCIENCES, INC. NA 106766, 106737, 106697

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention