BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 205311 · Received January 8, 1999

    Report

    Report Number
    2027148-1999-00003
    Event Type
    Injury
    Date Received
    January 8, 1999
    Date of Event
    August 3, 1998
    Report Date
    January 8, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 06/02/1998 IN GLABELLA. ONSET OF IMPLANT VISIBLE. IMPLANT EXTRUSION AND IMPLANT PALPABLE DURING 1998, EXACT DATE UNK. PT REVISED 07/06/1998 AND 08/03/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03601/98B081A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention DURICEF (06/01/1998 TO 06/05/1998).