BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUTCHISON SALINE FILL MAMMARY IMPLANT

    MDR report key: 509439 · Received January 30, 2004

    Report

    Report Number
    2320466-2004-00012
    Event Type
    Injury
    Date Received
    January 30, 2004
    Date of Event
    January 13, 2004
    Report Date
    January 29, 2004
    Manufacturer
    BIOSIL LTD.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DESCRIBE EVENT OR PROBLEM: SUSPECTED DEFLATION.

    Description of Event or Problem · 1

    DEFLATION RIGHT BREAST IMPLANT, WITH BILATERAL EXCHANGE USING ANOTHER BRAND.

    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 S5085/1

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention