BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 188998 · Received September 22, 1998

    Report

    Report Number
    2027148-1998-00059
    Event Type
    Injury
    Date Received
    September 22, 1998
    Date of Event
    June 1, 1998
    Report Date
    September 22, 1998
    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 09/02/1998 INTO BOTH NASOLABIAL FOLDS, CHIN, AND GLABELLA. ONSET OF LOSS OF CORRECTION 06/1998 IN GLABELLA, CHIN AND NASOLABIAL. IMPLANT(S) EXPLANTED, DATE AND SITE NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03047

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ZYPLAST IMPLANT (FROM 11/21/1995).