BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 204383 · Received December 29, 1998

    Report

    Report Number
    2027148-1998-00125
    Event Type
    Injury
    Date Received
    December 29, 1998
    Date of Event
    March 24, 1998
    Report Date
    December 29, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 01/06/1998 INTO THE UPPER VERMILION BORDERS. ONSET OF IMPLANT EXTRUSION AND IMPLANT VISIBLE 01/12/1998 IN PERIORAL AREA. TREATMENT 01/12/1998 CORTICOSTEROID, 12/17/1998 KEFLEX, 02/17/1998 REVISION AND 03/24/1998 EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03541/97L101A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 2. ZOVIRAX (01/15/1998 TO 01/24/1998).| 1. KEFLEX (01/05/1998 TO 01/13/1998),