BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCYTE

    MDR report key: 294842 · Received September 8, 2000

    Report

    Report Number
    2028403-2000-00007
    Event Type
    Injury
    Date Received
    September 8, 2000
    Date of Event
    July 18, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING IS THE REPORT BY RN, SENIOR MANAGER, MEDICAL AFFAIRS, ADVANCED TISSUE SCIENCES, INC., WHO BECAME AWARE OF THIS EVENT IN 2000 WHILE AT A MONITORING VISIT FOR STUDY TC-04-01-0200. "PT (PROTOCOL # TC-04-01-0200) WAS ENROLLED IN THE STUDY IN 2000. PT UNDERWENT A FULL FACE LASER RESURFACING ON THAT DAY. TWO CASSETTES OF TRANSCYTE WERE APPLIED TO PT'S RESURFACED FACE. PT WAS SEEN BY CERTIFIED CLINICAL RESIDENT COORDINATOR, AND M.D. IN 2000 FOR A POST RESURFACING FOLLOWUP VISIT. ON THIS DAY, THERE WERE 35% OF THE TRANSCYTE REMAINING ON THE PT'S FACE. THE PT COMPLAINED OF FACIAL "BURNING SINCE THE PROCEDURE". DR ORDERED A "PRECAUTIONARY CULTURE TODAY, RIGHT CHEEK." THE PT WAS SEEN FOR THE DAY 14 STUDY FOLLOW-UP IN 2000. AT THAT POINT THERE WAS ONLY 1% OF THE TRANSCYTE REMAINING ON THE FACE. DR NOTED THAT THE "PATIENT SCRAPED OFF AREAS OF ADHERENT MASK" AND "NOW HAS ITCHING AND BURNING SINCE MASK HAS COME OFF." CULTURE RESULTS FROM THE PREVIOUS VISIT REPORTED MANY COAGULASE NEGATIVE STAPHYLOCCUS, MANY BETA STREPTOCOCCUS GROUP B, MANY ALPHA STREPTOCOCCUS NOT S. PNEUMONIAE/NOT ENTEROCOCCUS. THE PT WAS GIVEN ORAL ANTIBIOTICS. THE EVENT IS REPORTED TO HAVE BEEN MILD AND TO BE RESOLVED IN 2000. THE SIGNED CASE REPORT FORM INDICATES THAT DR BELIEVES TRANSCYTE PROBABLY CAUSED OR CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSCYTE HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE MGR ADVANCED TISSUE SCIENCES, INC. NA 106798

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention