BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 236885 · Received August 20, 1999

    Report

    Report Number
    2027148-1999-00138
    Event Type
    Injury
    Date Received
    August 20, 1999
    Date of Event
    December 28, 1998
    Report Date
    August 20, 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

    PT IMPLANTED IN RIGHT AND LEFT UPPER VERMILLON BORDERS IN 1998. ONSET OF INFECTION IN PERIORAL 12/24/1998. PT TREATED WITH KEFLEX AND TRIPLE ANTIBIOTIC 12/24/1998. IMPLANT EXPLANTED IN 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03977/98K251A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention KEFLEX (12/08/1998 TO 12/1998).