BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 228024 · Received June 18, 1999

    Report

    Report Number
    2027148-1999-00083
    Event Type
    Injury
    Date Received
    June 18, 1999
    Date of Event
    November 30, 1998
    Report Date
    June 18, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT IMPLANTED IN 1998 IN THE UPPER AND LOWER VERMILION BORDERS. ONSET OF INFECTION AND EXTRUSION 03/02/1998. PATIENT TREATED WITH CEFTIN 03/02/1998, AND ROCEPHIN, TROVAN 03/05/1998. PATIENT REVISED 03/05/1998. IMPLANT EXPLANTED IN 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03422/97J201A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention BOVINE COLLAGEN IMPLANT, TYPE UNKNOWN (UNK TO UNK)