BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE FILLED BREAST IMPLANT

    MDR report key: 638782 · Received September 27, 2005

    Report

    Report Number
    2024601-2005-00568
    Event Type
    Injury
    Date Received
    September 27, 2005
    Date of Event
    August 3, 2005
    Report Date
    August 3, 2005
    Manufacturer
    INAMED-SANTA BARBARA
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEFT SIDE DEFLATION PER RGA, CAPSULAR CONTRACTURE GRADE I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE FILLED BREAST IMPLANT SALINE BREAST IMPLANT FWM INAMED-SANTA BARBARA STYLE 468 524865

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention