BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 274671 · Received April 19, 2000

    Report

    Report Number
    2027148-2000-00027
    Event Type
    Injury
    Date Received
    April 19, 2000
    Date of Event
    February 14, 2000
    Report Date
    April 19, 2000
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN 1999 IN LEFT UPPER VERMILION BORDER. ONSET OF SWELLING, TENDERNESS AND IMPLANT SHORTENING IN PERIORAL 01/1999. IMPLANT EXPLANTED IN 2000 AND PT TREATED WITH CEDAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K04722/99L341A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SOFTFORM IMPLANT.