BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 248665 · Received November 2, 1999

    Report

    Report Number
    2027148-1999-00188
    Event Type
    Injury
    Date Received
    November 2, 1999
    Date of Event
    May 13, 1999
    Report Date
    November 2, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN NASOLABIALS, UPPER VERMILION BORDER, AND ORAL COMMISSURES 1999. ONSET OF IMPLANT DISPLACEMENT AND SHORTENING 05/1999. IMPLANT WAS EXPLANTED IN 05/13/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03977/K03802

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 3. ZYPLAST IMPLANT (01/29/1999 TO 04/09/1999).| 1. KEFLEX (04/09/1999 TO 04/16/1999)| 2. FAMVIR (04/06/1999 TO 04/13/1999)