BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 228022 · Received June 18, 1999

    Report

    Report Number
    2027148-1999-00088
    Event Type
    Injury
    Date Received
    June 18, 1999
    Date of Event
    November 4, 1998
    Report Date
    June 18, 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 NASOLABIAL FOLDS IN 1998. ONSET OF GRANULOMA 09/24/1998. IMPLANT EXPLANTED IN 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 44 YR Required Intervention