BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 248643 · Received November 2, 1999

    Report

    Report Number
    2027148-1999-00185
    Event Type
    Injury
    Date Received
    November 2, 1999
    Date of Event
    May 13, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN 1999 IN NASOLABIAL FOLDS. ONSET OF SEROMA AND INFECTION 05/09/1999. PT TREATED CIPRO 05/12/1999. IMPLANT WAS EXPLANTED IN 1999.

    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 55 YR Required Intervention 3. LIDOCAINE WITH EPINEPHRINE (4/6/1999 TO 4/6/99)| 1. SULAR (TO 04/06/1999)| 2. MAXZIDE (TO 04/06/1999),