BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 284663 · Received June 27, 2000

    Report

    Report Number
    2027148-2000-00032
    Event Type
    Injury
    Date Received
    June 27, 2000
    Date of Event
    April 3, 2000
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT IMPLANTED IN 2000, IN THE UPPER VERMILION BORDER. ONSET OF INFECTION 03/2000, EXACT DATE UNKNOWN. PT TREATED WITH ANCEF 03/27/2000, 03/28/2000 AND CEFTIN AND ANCEF ON 04/03/2000. IMPLANT EXPLANTED IN 2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K04570/K03780

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention CEFTIN (2000 TO 03/14/2000).