BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 227915 · Received June 18, 1999

    Report

    Report Number
    2027148-1999-00104
    Event Type
    Injury
    Date Received
    June 18, 1999
    Date of Event
    January 1, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT IMPLANTED IN 1998 IN THE UPPER AND LOWER VERMILION BORDERS. ONSET OF IMPLANT SHORTENING AND PALPABLE IMPLANT 08/03/1998. IMPLANT EXPLANTED DURING 1998, EXACT DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC NA K03464/K03453

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention BOVINE COLLAGEN IMPLANT TYPE UNKNOWN| (TO 12/15/1998).