BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 220188 · Received April 21, 1999

    Report

    Report Number
    2027148-1999-00065
    Event Type
    Injury
    Date Received
    April 21, 1999
    Date of Event
    October 20, 1998
    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

    PT IMPLANTED 05/28/1998 IN THE UPPER AND LOWER VERMILION BORDERS. ONSET OF INFECTION 06/04/1998 IN PERIORAL. PT TREATED WITH CIPRO ON 06/04/1998, HYDROGEN PEROXIDE ON 06/18/1998, LEVAQUIN ON 06/19/1998, CIPRO ON 07/17/1998 AND 10/07/1998, AND NEOSPORIN 10/07/1998. IMPLANT EXPLANTED 10/20/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03594/98C351A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention CIPRO (05/28/1998 TO 06/01/1998)| BOVINE COLLAGEN IMPLANT, TYPE UNK, DATE UNK.