BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 262280 · Received February 10, 2000

    Report

    Report Number
    2027148-2000-00014
    Event Type
    Injury
    Date Received
    February 10, 2000
    Date of Event
    November 9, 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 1999 IN UPPER AND LOWER VERMILION BORDERS. ONSET OF INFECTION 09/02/1999. PT TREATED 09/02/1999 WITH KEFLEX. IMPLANT IN 1999. PT TREATED WITH CIPRO AND THE IMPLANT EXPLANTED IN 1999. IMPLANT EXPLANTED IN 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03956/98K241A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention KEFLEX (1999 TO 1999).