BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 220211 · Received April 21, 1999

    Report

    Report Number
    2027148-1999-00055
    Event Type
    Injury
    Date Received
    April 21, 1999
    Date of Event
    April 22, 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 04/06/1998 IN UPPER AND LOWER VERMILION BORDERS. ONSET OF BRUISING AND IMPLANT EXTRUSION IN PERIORAL 04/16/1998. IMPLANT EXPLANTED 04/22/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03464/K03422

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 1. FAMVIR (02/23/1998 TO 02/23/1998),| 2. ZYPLAST IMPLANT (11/05/1997 TO 02/11/1998).