BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORM TERINO MALAR SHELL

    MDR report key: 496204 · Received November 17, 2003

    Report

    Report Number
    2028924-2003-00002
    Event Type
    Injury
    Date Received
    November 17, 2003
    Date of Event
    September 26, 2003
    Report Date
    November 17, 2003
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED AN INFECTION AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFORM TERINO MALAR SHELL SILICONE FACIAL IMPLANT - MALAR LZK IMPLANTECH ASSOCIATES, INC. NA 611667

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention