BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 228093 · Received June 18, 1999

    Report

    Report Number
    2027148-1999-00086
    Event Type
    Injury
    Date Received
    June 18, 1999
    Date of Event
    November 11, 1998
    Report Date
    June 18, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN 1998 IN UPPER AND LOWER VERMILION BORDERS. ONSET OF IMPLANT EXTRUSION, INFECTION, PALPABLE IMPLANT, AND SCARRING 05/13/1998. ON 05/13/1998 IMPLANT REVISED EXCISED, AND PT TREATED WITH CIPRO. ON 08/15/1998 PT TREATED WITH TRIAMCINOLONE. ON 10/14/1998 SITE INCISED AND DRAINED AND PT TREATED WITH CIPRO. ON 11/11/1998 IMPLANT EXPLANTED AND PT TREATED WITH KEFLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03550/98A011A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention