BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMAGRAFT-TC

    MDR report key: 186947 · Received September 14, 1998

    Report

    Report Number
    2028403-1998-00020
    Event Type
    Other
    Date Received
    September 14, 1998
    Date of Event
    July 8, 1997
    Report Date
    September 10, 1998
    Manufacturer
    ADVANCED TISSUE SCIENCES,INC.
    Product Code
    MGR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE CONDUCTING AN AUDIT OF PRODUCT EXPERIENCES, R.N., AN ATS MEDICAL AFFAIRS ASSOCIATE, ELICITED THE FOLLOWING INFO. THE MEDICAL PERSONNEL AT THIS HOSP DID NOT BRING THIS TO CO'S ATTENTION AS A COMPLAINT. A 22 YR-OLD WHITE MALE WAS ADMITTED TO THE HOSP ON 06/24/1997 WITH A 23% TOTAL BODY SURFACE AREA (21% FULL THICKNESS) BURN ON HIS CHEST/ABDOMEN/NECK/LOWER FACE/BILATERAL UPPER EXTREMITIES AS THE RESULT OF A SUICIDE ATTEMPT. RELEVENT PAST HISTORY INCLUDED SCHIZOPHRENIA. PRIOR TO SURGERY THE PATIENT WAS TREATED WITH ANTIBIOTICS (SILVADENE, ANCEF) FOR CELLULLTIS AND GENERAL PREOPERATIVE COVERAGE. ON 06/30/1997 AND 07/02/1997 CULTURES SHOWED COAG.NEG.STAPH.AND E.COLI. WOUNDS WERE EXCISED 2 WEEKS AFTER BURN (07/07/1997) AND 7 PIECES OF DERMAGRATH-TC (D-TC) APPLIED TO THE CHEST AND ABDOMEN, AND COVERED WITH NEOPORIN SOAKED BULKY DRESSING, AND ANCEF CONTINUED UNTIL 7-9. CULTURES TAKEN AT SURGERY GREW PSEUDOMONAS AERUGINOSA SEPARATING FROM WOUND. ON 07/09/1997 SWAB CULTURE OF CHEST/SHOULDER UNDER D-TC WAS POSITIVE FOR PA. GENTAMICIN + PIPERACILLIN STARTED 07/09/1997. 75% OF THE D-TC WAS REMOVED, AND THE INFECTION CONTINUED TO BE TREATED. ON 07/24/1997 THE AREAS WERE SUCCESSFULLY AUTOGRATHED, AND AS OF 7-29 AUTOGRATH REMIANED IN PLACE. ACCORDING TO CO, IN THE PHYSICIAN'S OPINION THE INFECTION WAS NOT CAUSED BY D-TC.

    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. ZT8000 101348

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other