BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE FILLED BREAST IMPLANT

    MDR report key: 617133 · Received June 22, 2005

    Report

    Report Number
    2024601-2005-00361
    Event Type
    Injury
    Date Received
    June 22, 2005
    Date of Event
    August 30, 2004
    Report Date
    March 3, 2005
    Manufacturer
    INAMED-SANTA BARBARA
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEFT SIDE DEFLATION. FOLLOW UP FINDINGS: PER RGA, CAPSULAR CONTRACTURE GRADE III. ADDITIONAL FOLLOW UP FINDING OF FOLD FATIGUE REPORTED ON RGA. PER MD, FOLD FATIGUE IS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE FILLED BREAST IMPLANT SALINE BREAST IMPLANT FWM INAMED-SANTA BARBARA STYLE 363 551991

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention