BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 204379 · Received December 29, 1998

    Report

    Report Number
    2027148-1998-00124
    Event Type
    Injury
    Date Received
    December 29, 1998
    Date of Event
    March 23, 1998
    Report Date
    December 29, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 02/25/1998 IN UPPER VERMILION. ONSET OF INFECTION, IMPLANT EXTRUSION AND EDEMA IN LIPS 02/25/1998. PT TREATED WITH THE FOLLOWING, 02/26/1998 COOL COMPRESSES, 03/02/1998 CEFTIN, 03/05/1998, TROVAFLOXACIN MESYLATE, 03/05/1998, ROCEPHIN, 03/13/1998, BACTROBAN, 03/13/1998, WARM COMPRESSES, 03/17/1998, TROVAFLOXACIN MESYLATE, 03/23/1998 REVISED.

    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 31 YR Required Intervention 2. ZYPLAST IMPLANT (TO 01/12/1998).| 4. COOL COMPRESSES (02/25/1998 TO 02/25/1998).| 1. TRI-LEVLEN (TO 02/25/1998),| 3. CIDEX (02/25/1998 TO 1998),