BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 266470 · Received February 28, 2000

    Report

    Report Number
    2027148-2000-00016
    Event Type
    Injury
    Date Received
    February 28, 2000
    Date of Event
    November 29, 1999
    Report Date
    February 28, 2000
    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 1999 IN LOWER VERMILION BORDER. ONSET OF INFECTION 10/25/1999. PATIENT TREATED 10/25/1999 WITH KEFLEX. THE IMPLANT WAS EXPLANTED 1999 AND THE PATIENT WAS TREATED WITH DICLOXACILLIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K04570/99G301A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention ANTIBIOTIC (10/14/1999 TO 10/20/1999).