BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 248634 · Received November 2, 1999

    Report

    Report Number
    2027148-1999-00191
    Event Type
    Injury
    Date Received
    November 2, 1999
    Date of Event
    May 26, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN NASOLABIAL FOLDS IN 1999. ONSET OF IMPLANT SHORTENING, DISPLACEMENT, VISIBLE 04/02/1999. IMPLANT EXPLANTED IN 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K04219/98M191A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 2. LIDOCAINE WITH EPINEPHRINE (3/25/99 TO 3/25/99)| 1. SYNTHROID (TO 03/25/1999)