BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 296217 · Received September 11, 2000

    Report

    Report Number
    2027148-2000-00051
    Event Type
    Injury
    Date Received
    September 11, 2000
    Date of Event
    March 29, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 1999 IN THE UPPER AND LOWER LIPS. ONSET OF ERYTHEMA AND PRURITUS AND OTHER LOCAL NON-IMMUNE SYMPTOMS 01/2000. PT TREATED 3/29/2000 WITH DIFLUCAN, 5/2/2000 WITH ARISTOCORT AND MEDROL AND TREATED WITH ARISTOCORT ON 6/5/00, 6/29/00, 7/7/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03977/K03601

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention COLLAGEN-NO DATES.