BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMAGRAFT

    MDR report key: 215596 · Received March 24, 1999

    Report

    Report Number
    2028403-1999-00001
    Event Type
    Injury
    Date Received
    March 24, 1999
    Date of Event
    February 19, 1999
    Report Date
    March 24, 1999
    Manufacturer
    ADVANCED TISSUE SCIENCES, INC.
    Product Code
    MGR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS 62 YEAR OLD FEMALE WAS ENROLLED IN A UNITED KINGDOM CLINICAL STUDY (NBT DCT 98/01) WHICH WAS DESIGNED TO STUDY VARIOUS TYPES OF SKIN ULCERS. THIS PT HAD AN ULCER ON THE RIGHT LEG OF A RHEUMATOID/VASCULITIC ETIOLOGY, AND THE PT WAS TAKING STEROIDS AND OTHER ANTI-INFLAMMATORY MEDICATION. SHE REC'D AN APPLICATION OF DERMAGRAFT ON 2/19/99 AND TWO HOURS LATER WAS NOTED TO HAVE CELLULITIS IN THE RIGHT LEG. ON THE CASE REPORT FROM THE PHYSICIAN DESCRIBED THE EVENT AS MILD, BUT STILL HOSPITALIZED THE PT ON 2/20/99 AND ADMINISTERED INTRAVENOUS ANTIBIOTICS. AS OF THE DATE OF THIS REPORT THE PT IS IMPROVED AND REMAINS ON ANTIBIOTICS IN THE HOSP. REGARDING THE RELATIONSHIP OF THE ADVERSE EVENT TO DERMAGRAFT, GIVEN A CHOICE BETWEEN "HIGHLY PROBABLE", "PROBABLE", "POSSIBLE", "REMOTE" AND "NONE", THE PHYSICIAN CHECKED "REMOTE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMAGRAFT Implant HUMAN FIBROBLAST-DERIVED SKIN SUBSTITUTE MGR ADVANCED TISSUE SCIENCES, INC. ZT5000 104990

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization SINCE 1996,| SINCE 1989,| SINCE 1994.| 1. AZATHIOPRINE (ANTI-INFLAMMATORY) 150 MG ORALLY| 1998 AND| 2. PREDNISOLONC (STEROID) 10MG ORALLY SINCE 1994,| ORALLY SINCE 1979.| 3. DIDRINAC (BONE DENSITY) 1.25G ORALLY SINCE 1996| 4. FERROUS SULPHATE (IRON SUPPLEMENT) 200MG ORALLY| 7. VITAMIN B (VITAMIN SUPPLEMENT) DOSE NOT KNOWN| 5. ALPHA CAPS (VITAMIN D SUPPLEMENT) 1 MG ORALLY| 6. TYLEX (ANALGESIC) DOSE NOT KNOWN, ORALLY SINCE