BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUTCHISON

    MDR report key: 840208 · Received April 16, 2007

    Report

    Report Number
    3005607434-2007-00017
    Event Type
    Other
    Date Received
    April 16, 2007
    Date of Event
    March 7, 2007
    Report Date
    March 14, 2007
    Manufacturer
    BIOSIL LTD
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEFLATION OF RIGHT BREAST IMPLANT. BILATERAL REPLACEMENT SURGERY SCHEDULED FOR JUNE 07. (LEFT NON DEFLATED: HSH-0500, LOT S6302/1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTCHISON SALINE BREAST IMPLANT FWM BIOSIL LTD SMOOTH, HIGH S-5932/1

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other