BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 254815 · Received December 15, 1999

    Report

    Report Number
    2027148-1999-00225
    Event Type
    Injury
    Date Received
    December 15, 1999
    Date of Event
    July 19, 1999
    Report Date
    December 15, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN 1999 IN THE UPPER VERMILION BORDER. ONSET OF INFECTION IN PERIORAL 7/13/1999. ON 7/13/1999 PT TREATED WITH CEFADROXIL. IMPLANT 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 K03615/98C381A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention EPINEPHRINE (6/21/1999 TO 6/21/1999).| KEFLEX (6/21/1999 TO 7/1/1999),| XYLOCAINE (6/21/1999 TO 6/24/1999),