BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 173920 · Received June 22, 1998

    Report

    Report Number
    2027148-1998-00043
    Event Type
    Injury
    Date Received
    June 22, 1998
    Date of Event
    February 5, 1998
    Report Date
    June 22, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 12/04/1997 INTO THE UPPER/LOWER VERMILION BORDERS. ONSET OF INFECTIN AND IMPLANT EXTRUSION 12/25/1997, IN PERIORAL AREA. INTERVENTION 02/05/1998 BY AUGMENTATION, WARM COMPRESSES AND EXPLANTATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention 4. HEAD ELEVATION (12/04/1997 TO 12/11/1997).| 2. POLYSPORIN (12/04/1997 TO 12/11/1997),| 3. COOL COMPRESSES (12/04/1997 TO 12/05/1997),| 1. ZYPLAST IMPLANT(09/05/1997 TO 11/13/1997),