BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 231380 · Received July 9, 1999

    Report

    Report Number
    2027148-1999-00119
    Event Type
    Injury
    Date Received
    July 9, 1999
    Date of Event
    January 18, 1999
    Report Date
    July 9, 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

    PATIENT IMPLANTED IN MENTAL FOLD, UPPER AND LOWER VERMILION BORDERS AND NASALABIAL FOLDS IN 1998. ONSET OF EXTRUSION AND INFECTION 01/1999 AT CHIN, IMPLANTS REVISED AND PATIENT TREATED WITH ANTIBIOTICS IN 1999. PAITENT AGAIN TREATED WITH ANTIBIOTICS 01/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03601/K03594

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention BOVINE COLLAGEN IMPLANT TYPE UNKNOWN