BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 227888 · Received June 18, 1999

    Report

    Report Number
    2027148-1999-00074
    Event Type
    Injury
    Date Received
    June 18, 1999
    Date of Event
    November 13, 1998
    Report Date
    June 18, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT IMPLANTED 1998 IN NASOLABIAL FOLDS. ONSET OF WOUND DRAINAGE 09/24/1998 IN NASOLABIAL. PATIENT TREATED WITH MINOCYCLINE ON 10/08/98, DICOXACILLIN ON 10/13/1998, REVISED 11/13/1998 AND 12/24/1998, AND TREATED WITH DOXYCYCLINE 12/24/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC NA K03660/98C341A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention BOVINE COLLAGEN IMPLANT TYPE UNK (TO 11/23/1998),| BOTOX (TO 11/23/1998).