BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 296227 · Received September 11, 2000

    Report

    Report Number
    2027148-2000-00049
    Event Type
    Injury
    Date Received
    September 11, 2000
    Date of Event
    June 23, 2000
    Report Date
    September 11, 2000
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 1999 IN UPPER AND LOWER VERMILION BORDERS. ONSET OF IMPLANT BUCKLING/BOWING AND SHORTENING, DATE UNKNOWN. IMPLANT EXPLANTED IN 2000 AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03977/98K251A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention PREMARIN-NO DATES, WILLBUTRIN-NO DATES,| RETIN A-NO DATES.