BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUTCHISON SALINE FILL MAMMARY IMPLANT

    MDR report key: 517182 · Received March 15, 2004

    Report

    Report Number
    2320466-2004-00032
    Event Type
    Injury
    Date Received
    March 15, 2004
    Date of Event
    January 30, 2004
    Report Date
    March 11, 2004
    Manufacturer
    BIOSIL LTD.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEFLATION RIGHT SALINE IMPLANT WITH BILATERAL EXCHANGE USING ANOTHER BRAND. UNKNOWN IF INITIAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTCHISON SALINE FILL MAMMARY IMPLANT SALINE BREAST IMPLANT FWM BIOSIL LTD. ROUND SMOOTH S2704/1

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR