BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 173927 · Received June 22, 1998

    Report

    Report Number
    2027148-1998-00040
    Event Type
    Injury
    Date Received
    June 22, 1998
    Date of Event
    February 1, 1998
    Report Date
    June 22, 1998
    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 11/19/1997 INTO THE RIGHT AND LEFT MARIONETTE LINES. ONSET OF INFECTION AND IMPLANT DISPLACEMENT 02/1998 IN PERIORAL AREA. IMPLANT EXPLANTED AND ANTIBIOTIC PRESCRIBED 02/1998.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention