BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 249360 · Received November 2, 1999

    Report

    Report Number
    2027148-1999-00213
    Event Type
    Injury
    Date Received
    November 2, 1999
    Date of Event
    June 21, 1999
    Report Date
    November 2, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 04/09/1999 IN UPPER VERMILION BORDER. ONSET OF IMPLANT EXTRUSION AND EDEMA 06/20/1999. PT TREATED 06/21/1999 WITH PENICILLIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K04467/99D281A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention CIPRO (TO 06/21/1999).