BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 242493 · Received September 27, 1999

    Report

    Report Number
    2027148-1999-00155
    Event Type
    Injury
    Date Received
    September 27, 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 BOTH NASOLABIAL FOLDS AND BOTH ORAL COMMISSURES. ONSET OF IMPLANT SHORTENING IN PERIORAL 11/06/1998. IMPLANT EXPLANTED, DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03784/K03856

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention