BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 372926 · Received January 16, 2002

    Report

    Report Number
    2027148-2001-00022
    Event Type
    Injury
    Date Received
    January 16, 2002
    Date of Event
    November 12, 2001
    Report Date
    January 16, 2002
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 2001 IN LOWER LIP. AFTER SEVERAL REVISIONS DUE TO EXTRUSION, PHYSICIAN EXPLANTED DEVICE LATER IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K05444/00J281A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention