BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 196818 · Received November 12, 1998

    Report

    Report Number
    2027148-1998-00111
    Event Type
    Injury
    Date Received
    November 12, 1998
    Date of Event
    April 28, 1998
    Report Date
    November 12, 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 IN UPPER AND LOWER VERMILION BORDERS ON 03/19/1998. ONSET OF SYMPTOMS 03/1998 INCLUDES IMPLANT EXTRUSION, WOUND DRAINAGE AND INFECTION. IMPLANT REVISION 03/1998. TREATED WITH CEFTIN AND BETADINE 03/1998. IMPLANT EXPLANTED 04/22/1998 AND TREATED WITH CIPRO.

    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 51 YR Required Intervention 1. KEFLEX (03/19/1998 TO 03/25/1998),| 2. BACITRACIN (03/19/1998 TO 03/25/1998),| 3. ALLODERM (TO 03/19/1998).