BEUDAMED
    FDA Adverse Event Injury Summary report: N

    27-120601

    MDR report key: 619318 · Received June 29, 2005

    Report

    Report Number
    2024601-2005-00376
    Event Type
    Injury
    Date Received
    June 29, 2005
    Date of Event
    October 6, 2004
    Report Date
    October 6, 2004
    Manufacturer
    SANTA BARBARA
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RADIOLOGY REPORT STATES "THERE IS A READIAL FOLD OF THE IMPLANT NOTED IN THE INFEROLATERAL SUBAREOLAR REGION. THERE IS A SMALL EFFUSION WITHIN THIS RADIAL FOLD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 27-120601 GEL BREAST IMPLANT FTR SANTA BARBARA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention