BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 296250 · Received September 11, 2000

    Report

    Report Number
    2027148-2000-00045
    Event Type
    Injury
    Date Received
    September 11, 2000
    Date of Event
    May 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 2000 IN UPPER LEFT VERMILION BORDER. ONSET OF IMPLANT EXTRUSION AND INFECTION 2000. PT TREATED 5/9/2000 WITH KEFLEX AND THE IMPLANT WAS EXPLANTED IN 2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K04474/99M301A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention LEVOTHYROXINE-NO DATES.| PROZAC-NO DATES, NITROFURANTOIN-NO DATES,