BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 196994 · Received November 12, 1998

    Report

    Report Number
    2027148-1998-00097
    Event Type
    Injury
    Date Received
    November 12, 1998
    Date of Event
    May 6, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN VERMILION BORDERS 03/24/1998. ONSET OF IMPLANT DISPLACEMENT, LOSS OF CORRECTION AND FEVER 04/06/1998. ANCEF PRESCRIBED 03/26/1998. IMPLANT EXPLANTED 05/06/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03567/98B021A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 4. LASER TREATMENT (FROM 03/24/1998).| 2. CECLOR (03/22/1998 TO 03/24/1998),| 3. FACE LIFT PROCEDURE (FROM 03/24/1998).| 1. BREAST IMPLANT(S) TYPE UNK (FROM 03/24/1998),