BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 220197 · Received April 21, 1999

    Report

    Report Number
    2027148-1999-00068
    Event Type
    Injury
    Date Received
    April 21, 1999
    Date of Event
    October 27, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN UPPER AND LOWER VERMILION BORDERS 10/16/1998. ONSET OF INFECTION 10/21/1998. PT TREATED WITH PENICILLIN AND CIPRO 10/21/1998. THE IMPLANT WAS EXPLANTED 10/27/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03409/97J091A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention 1. ZOVIRAX (10/14/1998 TO 10/20/1998),| 2. ZITHROMAX (10/14/1998 TO 10/18/1998).