BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 248628 · Received November 2, 1999

    Report

    Report Number
    2027148-1999-00201
    Event Type
    Injury
    Date Received
    November 2, 1999
    Date of Event
    June 9, 1999
    Report Date
    November 2, 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 1999 IN NASOLABIAL FOLDS. ONSET OF INFECTION VISIBLE IMPLANT AND SCARRING 05/1999. PT TREATED WITH CORTISONE 05/1999 AND ZITHROMAX 05/28/1999. IMPLANT EXPLANTED AND SCAR REVISION 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03594/98C351A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention ZITHROMAX (05/13/1999 TO 05/17/1999).| TROVAN (05/13/1999 TO 05/13/1999),