BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 176564 · Received July 10, 1998

    Report

    Report Number
    2027148-1998-00045
    Event Type
    Injury
    Date Received
    July 10, 1998
    Date of Event
    January 8, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 01/08/1998 INTO UPPER AND LOWER VERMILION BORDERS. INSERTION DIFFICULTIES WERE EXPERIENCED DURING IMPLANTATION. ONSET OF IMPLANT DISPLACEMENT 01/08/1998. IMPLANT EXPLANTED 02/16/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03454/97K111A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention GORE TEX IMPLANT| RETIN-A (TO 01/08/1998),| VALTREX (01/07/1998 TO 01/17/1998),| COOL COMPRESSES (01/08/1998 TO 01/10/1998),| ARISTOCORY FORTE (01/08/1998 TO 01/08/1998),| HEAD ELEVATION (01/08/1998 TO 01/11/1998),| ZOLOFT (TO 01/08/1998),| ERYTHROMYCIN (01/08/1998 TO 01/15/1998),| POLYSPORIN (01/08/1998 TO 01/10/1998)| TETRACYCLINE (TO 01//08/1998),| BOVINE COLLAGEN IMPLANT TYPE UNKNOWN,| POLYSPORIN (FROM 02/16/1998).| ISLOGEN IMPLANT,