BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 196848 · Received November 12, 1998

    Report

    Report Number
    2027148-1998-00110
    Event Type
    Injury
    Date Received
    November 12, 1998
    Date of Event
    January 1, 1998
    Report Date
    November 12, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 11/25/1997 IN THE NASOLABIAL FOLDS. ONSET OF LOSS OF CORRECTION SYMPTOMS 04/07/1998. IMPLANT EXPLANTED 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03422/97J201A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention 1. BOCINE COLLAGEN IMPLANT TYPE UNK TO (04/07/1998| 4. HEAD ELEVATION (11/25/1997 TO 1997).| 3. COOL COMPRESSES (11/25/1997 TO 11/25/1997),| 2. KEFLEX (11/25/1997 TO 11/30/1997),