BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 204392 · Received December 29, 1998

    Report

    Report Number
    2027148-1998-00129
    Event Type
    Injury
    Date Received
    December 29, 1998
    Date of Event
    April 8, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT IMPLANTED 03/03/1998 IN UPPER AND LOWER VERMILION BORDERS. ON 03/03/1998, ONSET OF SWELLING, SKIN DRY, IMPLANT VISIBLE AND BURNING SKIN IN PERIORAL AREA. PATIENT ALSO HAD HEADACHE. ON 04/08/1998 IMPLANT EXPLANTED AND PATIENT TREATED WITH ZITHROMAX.

    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 56 YR Required Intervention 1. ZITHROMAX (03/03/1998 TO 03/13/1998),| 2. BOVINE COLLAGEN IMPLANT TYPE UNKNOWN (1992 TO| 1992).