BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 192743 · Received October 19, 1998

    Report

    Report Number
    2027148-1998-00088
    Event Type
    Injury
    Date Received
    October 19, 1998
    Date of Event
    May 27, 1998
    Report Date
    October 19, 1998
    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 BOTH NASOLABIAL FOLDS AND BOTH ORAL COMMISSURES ON 05/20/1998. ONSET OF WOUND DRAINAGE, IMPLANT EXTRUSION AND INFECTION 05/27/1998 IN NASOLABIAL AND PERIORAL AREAS. PT REVISED 05/27/1998 AND 06/19/1998. CEPHALEXIN PRESCRIBED 06/19/1998. IMPLANT EXPLANTED 06/24/1998, SITES UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03551/98B011A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention