BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUTCHISON

    MDR report key: 517139 · Received March 19, 2004

    Report

    Report Number
    2320466-2004-00043
    Event Type
    Injury
    Date Received
    March 19, 2004
    Report Date
    March 19, 2004
    Manufacturer
    BIOSIL LTD.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DESCRIBE EVENT OR PROBLEM: SUSPECTED DEFLATION.

    Description of Event or Problem · 1

    DEFLATION OF LEFT IMPLANT, BILATERAL, REPLACMENT WITH ANOTHER BRAND DUE TO HUTCHISON IDE STATUS. INITIAL USE OF DEVICE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTCHISON SALINE BREAST IMPLANT FWM BIOSIL LTD. SMOOTH ROUND S5160/1

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention