BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 207246 · Received January 20, 1999

    Report

    Report Number
    2027148-1999-00032
    Event Type
    Injury
    Date Received
    January 20, 1999
    Date of Event
    July 1, 1998
    Report Date
    January 20, 1999
    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 IN BOTH UPPER VERMILION BORDERS ON 07/1998. ONSET OF HERPES SIMPLEX, INFECTION AND IMPLANT EXTRUSION 07/1998. PT TREATED WITH VALTREX AND KEFLEX 07/1998.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention 2. FAT INJECTIONS (TO 07/1998),| 3. PALQUENIL SULFATE (TO 07/1998).| 1. KEFLEX (07/1998 TO 07/1998),