BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 205316 · Received January 8, 1999

    Report

    Report Number
    2027148-1999-00007
    Event Type
    Injury
    Date Received
    January 8, 1999
    Date of Event
    July 16, 1998
    Report Date
    January 8, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN UPPER AND LOWER VERMILION BORDERS 12/01/1997. ONSET OF SWELLING, PALPABLE, VISIBLE AND IMPLANT SHORTENING 12/02/1997. PT TREATED WITH KENALOG 12/17/1997, REVISED 01/12/1998 TREATED WITH KENALOG 03/11/1998, HYDROCORTISONE 04/13/1998, REVISED 07/16/1998 AND TREATED WITH KENALOG 07/16/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03048

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 1. BACTROBAN (12/01/1997 TO 12/1997),| 2. CEFTIN (11/30/1997 TO 12/06/1997),| 3. VALTREX (11/30/1997 TO 12/06/1997).