BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 262337 · Received February 10, 2000

    Report

    Report Number
    2027148-2000-00001
    Event Type
    Injury
    Date Received
    February 10, 2000
    Date of Event
    October 4, 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 RIGHT NASOLABIAL FOLD IN 1998. ONSET OF ERYTHEMA AND WOUND DRAINAGE 09/13/1999. PT TREATED WITH CORTICOSTEROID 09/13/1999. 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 K03536/97L091A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention ZYDERM IMPLANT (FROM 01/19/1999).