BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUCHISON SALINE FILL MAMMARY IMPLANT

    MDR report key: 509370 · Received January 30, 2004

    Report

    Report Number
    2320466-2004-00006
    Event Type
    Injury
    Date Received
    January 30, 2004
    Date of Event
    December 9, 2003
    Report Date
    January 28, 2004
    Manufacturer
    BIOSIL LTD.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFECTED RIGHT BREAST IMPLANT. AFTER DISSECTION THE CAPSULE WAS NOTED TO BE SIGIFICANTLY THICKENED AND SEVERELY CONTRACTED. THE IMPLANT CONTAINED BROWNISH FLUID, NO PUNCTURE OR LEAK WAS NOTED. THE CAPSULE WAS SEVERELY THICKENED IN AN AREA OF SKIN INFLAMMATION. CAPSULECTOMY PERFORMED. IMPLANT REMOVED AND NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUCHISON SALINE FILL MAMMARY IMPLANT SALINE BREAST IMPLANT FWM BIOSIL LTD. ROUND SMOOTH S8365/1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention