BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 220204 · Received April 21, 1999

    Report

    Report Number
    2027148-1999-00067
    Event Type
    Injury
    Date Received
    April 21, 1999
    Date of Event
    October 5, 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 11/18/1997 IN LOWER VERMILION BORDER. ONSET OF LOSS OF AUGMENTATION DURING 1998. IMPLANT EXPLANTED 10/05/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03507/97K221A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention BOVINE COLLAGEN IMPLANT, TYPE UNK (FROM 10/23/98).