BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 188979 · Received September 22, 1998

    Report

    Report Number
    2027148-1998-00063
    Event Type
    Injury
    Date Received
    September 22, 1998
    Date of Event
    July 1, 1998
    Report Date
    September 22, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN UPPER AND LOWER VERMILION BORDERS ON 04/13/1998. ONSET OF SWELLING, PAIN, IMPLANT EXTRUSION AND INFECTION 04/1998 IN PERIORAL AREA. IMPLANT EXPLANTED 07/22/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03576/98B061A

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention 2. KEFLEX (04/13/1998 TO 04/1998).| 3. BOVINE COLLAGEN IMPLANT (TYPE UNK).| 1. GORE-TEX IMPLANT (FROM 1994).