BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 236899 · Received August 20, 1999

    Report

    Report Number
    2027148-1999-00140
    Event Type
    Injury
    Date Received
    August 20, 1999
    Date of Event
    February 25, 1999
    Report Date
    August 20, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN 1999 IN THE UPPER AND LOWER VERMILION BORDERS. ONSET OF INFECTION AND IMPLANT EXTRUSION 02/05/1999 IN PERIORAL. PT TREATED WITH DURICEF 02/05/1999, REVISED IN 1999. THE IMPLANT WAS EXPLANTED IN 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03979/98L241A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention