BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUTCHISON

    MDR report key: 602601 · Received May 10, 2005

    Report

    Report Number
    2320466-2005-00061
    Event Type
    Injury
    Date Received
    May 10, 2005
    Report Date
    May 6, 2005
    Manufacturer
    BIOSIL LTD
    Product Code
    FWN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEFLATION OF LEFT BREAST IMPLANT. BILATERAL EXCHANGE WITH INAMED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTCHISON SALINE BREAST IMPLANT FWN BIOSIL LTD SMOOTH,LOW S-6493-1

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention