BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 173930 · Received June 22, 1998

    Report

    Report Number
    2027148-1998-00041
    Event Type
    Injury
    Date Received
    June 22, 1998
    Date of Event
    March 3, 1998
    Report Date
    June 22, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED INTO THE NASOLABIAL 01/22/1998. ONSET OF IMPLANT EXTRUSION IN NASOLABIAL, EXACT DATE UNK. IMPLANT EXPLANTED 03/03/1998. PT TREATED WITH ANTIBIOTICS, EXACT DATE UNK. NO OTHER INFO AVAILABLE.

    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 NO INFO Required Intervention ANTIBIOTIC (FROM 1998).