BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 220229 · Received April 21, 1999

    Report

    Report Number
    2027148-1999-00057
    Event Type
    Injury
    Date Received
    April 21, 1999
    Date of Event
    October 22, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED 02/23/1998 IN NASOLABIAL FOLDS. ONSET OF INFECTION GRANULOMA AND DELAYED HEALING IN NASOLABIAL. WOUND EXCISED ON 09/22/1998 AND PT TREATED WITH CEFTIN ON 09/25/1998. WOUND EXCISED ON 10/08/1998. THE IMPLANT WAS EXPLANTED 10/22/1998 AND THE PT TREATED WITH AUGMENTIN ON 10/20/1998 AND 11/08/1998.

    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 49 YR Required Intervention FAMVIR (02/23/1998 TO 02/23/1998),| ZYPLAST IMPLANT (11/05/1997 TO 02/11/1998).