BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 288649 · Received August 4, 2000

    Report

    Report Number
    2027148-2000-00036
    Event Type
    Injury
    Date Received
    August 4, 2000
    Date of Event
    May 15, 2000
    Report Date
    August 4, 2000
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED INTO THE UPPER AND LOWER VERMILION BORDERS IN 2000. ONSET OF EDEMA IN LIPS IN 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 K03698/99E321A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention PREMARIN (UNK TO UNK), SYNTHROID (UNK TO UNK).