BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUTCHISON

    MDR report key: 517133 · Received March 19, 2004

    Report

    Report Number
    2320466-2004-00046
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEFLATED RIGHT BREAST IMPLANT, BILATERAL OPEN CAPSULOTOMY, REPLACE BILATERAL IMPLANTS WITH ANOTHER BRAND. UNKNOWN IF INITIAL USE.

    Description of Event or Problem · 1

    DESCRIBE EVENT OR PROBLEM: SUSPECTED DEFLATION:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTCHISON SALINE BREAST IMPLANT FWM BIOSIL LTD. ROUND SMOOTH S2382/1

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention