BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 288642 · Received August 4, 2000

    Report

    Report Number
    2027148-2000-00038
    Event Type
    Injury
    Date Received
    August 4, 2000
    Date of Event
    May 10, 2000
    Report Date
    August 4, 2000
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN 1999 IN THE UPPER RIGHT AND LEFT AND LOWER VERMILION BORDERS. ONSET OF INFECTION AND IMPLANT SHORTENING IN 2000. IMPLANT EXPLANTED IN 2000, AND PT TREATED WITH Z-BEC. IMPLANT EXPLANTED IN 2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K04598/99G401A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention