BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 178739 · Received July 22, 1998

    Report

    Report Number
    2027148-1998-00051
    Event Type
    Injury
    Date Received
    July 22, 1998
    Date of Event
    April 8, 1998
    Report Date
    July 22, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED INTO UPPER AND LOWER VERMILION BORDERS ON 03/03/1998. ONSET OF SWELLING, DRY SKIN, EXTRUSION AND BURNING SKIN 03/03/1998 IN PERIORAL AREA. IMPLANT EXPLANTED 04/08/1998.

    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 56 YR Required Intervention 1) ZITHROMAX (03/03/1998 TO 03/13/1998),| 2) BOVINE COLLAGEN IMPLANT, TYPE UNK (FROM 1992).