BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 254957 · Received December 15, 1999

    Report

    Report Number
    2027148-1999-00214
    Event Type
    Injury
    Date Received
    December 15, 1999
    Date of Event
    July 5, 1999
    Report Date
    December 15, 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 LEFT NASOLABIAL FOLDS IN 1999. ONSET OF WOUND DRAINAGE AND INFECTION 05/1999. PT TREATED WITH KEFTAB AND BACITRACIN 06/17/1999. IMPLANT EXPLANTED 1999 AND PT TREATED WITH LEVOQUIN.

    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 54 YR Required Intervention BOTOX (START DATE UNK)