BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 296221 · Received September 11, 2000

    Report

    Report Number
    2027148-2000-00050
    Event Type
    Injury
    Date Received
    September 11, 2000
    Date of Event
    April 10, 2000
    Report Date
    September 11, 2000
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 2000 IN THE UPPER VERMILION BORDER. ONSET OF EDEMA AND IMPLANT SHORTENING ELEVEN DAYS, LATE. PT TREATED 4/10/00 WITH MEDROL DOSE PACK, 4/27/00 WITH PREDNISONE AND KEFLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA KO4474/99M301A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention