BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 191091 · Received October 9, 1998

    Report

    Report Number
    2027148-1998-00082
    Event Type
    Injury
    Date Received
    October 9, 1998
    Date of Event
    May 19, 1998
    Report Date
    October 9, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN NASOLABIAL FOLDS ON 05/15/1998. ONSET OF INFECTION 05/19/1998 IN NASOLABIAL AREA. IMPLANT EXPLANTED 05/19/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03500/97K231A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PREMPRO (TO 06/02/1998, PROZAC (TO 06/02/1998),| VALIUM (TO 06/02/1998).