BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 248618 · Received November 2, 1999

    Report

    Report Number
    2027148-1999-00198
    Event Type
    Injury
    Date Received
    November 2, 1999
    Date of Event
    June 8, 1999
    Report Date
    November 2, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN UPPER VERMILION BORDER ON 03/30/1999. ONSET OF INFECTION 06/06/1999 IN PERIORAL. PT TREATED WITH AUGMENTIN 06/08/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC NA K03956/98K241A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention AUGMENTIN (TO 06/08/1999).