BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 296238 · Received September 11, 2000

    Report

    Report Number
    2027148-2000-00047
    Event Type
    Injury
    Date Received
    September 11, 2000
    Date of Event
    May 31, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 2000 IN THE LOWER LIP. ONSET OF INFECTION AND ABSCESS 2000. SITE DRAINED 5/31/2000 AND PT TREATED 6/7/2000 WITH ZITHROMAX, 6/14/2000 WITH BACTRIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03698/99E321A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention