BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE BREAST IMPLANT

    MDR report key: 600437 · Received May 5, 2005

    Report

    Report Number
    2024601-2005-00241
    Event Type
    Injury
    Date Received
    May 5, 2005
    Date of Event
    February 23, 2005
    Report Date
    March 15, 2005
    Manufacturer
    INAMED CORPORATION
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RIGHT SIDE DEFLATION. FOLLOW UP FINDINGS: PER RGA ADDITIONAL EVENT OF FOLD FLAW

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE BREAST IMPLANT SALINE BREAST IMPLANT FWM INAMED CORPORATION STYLE 468 530062

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention