BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 179270 · Received July 28, 1998

    Report

    Report Number
    2027148-1998-00053
    Event Type
    Injury
    Date Received
    July 28, 1998
    Date of Event
    December 16, 1997
    Report Date
    July 28, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 11/18/1997 INTO THE NASOLABIAL FOLDS. ONSET OF IMPLANT DISPLACEMENT 12/16/1997. ON 03/17/1998 IMPLANT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03422/97J201A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention 8) BACITRACIN (03/17/1998 TO 03/23/1998).| 6) MINOCYCLINE (03/17/1998 TO 03/24/1998),| 1) EXTRATEST (TO 11/18/1997),| 4) COOL COMPRESSES (11/18/1997 TO 11/21/1997),| 3) BACITRACIN (11/18/1997 TO 11/24/1997),| 5) HEAD ELEVATION (03/17/1998 TO 03/19/1998),| 2) MINOCYCLINE (11/18/1997 TO 11/25/1997),| 7) COOL COMPRESSES (03/17/1998 TO 03/20/1998),