BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE BREAST IMPLANTS

    MDR report key: 752747 · Received June 22, 2005

    Report

    Report Number
    MW1035810
    Event Type
    Injury
    Date Received
    June 22, 2005
    Date of Event
    June 22, 2004
    Report Date
    June 22, 2005
    Manufacturer
    INMED
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD BREAST IMPLANTS PUT IN 2004. THEY WERE EXPLANTED IN 2005. PT IS STILL SICK FROM THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE BREAST IMPLANTS * FWM INMED NN2261 468

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening