BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGHAN BREAST IMPLANT SALINE

    MDR report key: 2993151 · Received March 5, 2013

    Report

    Report Number
    MW5029194
    Event Type
    Death
    Date Received
    March 5, 2013
    Date of Event
    March 1, 2012
    Report Date
    March 5, 2013
    Manufacturer
    (MCGHAN) MENTOR
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT'S HUSBAND CALLED REGARDING SALINE BREAST IMPLANTS HIS WIFE RECEIVED IN 2002. HUSBAND BELIEVES THE IMPLANT CAUSE HIS WIFE TO BE DIAGNOSED WITH LUPUS, FIBROMYALGIA, LUNG DISEASE, AND RESPIRATORY FAILURE, WHICH LEAD TO HER DEATH IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94321 MCGHAN BREAST IMPLANT SALINE BREAST IMPLANT SALINE FWM (MCGHAN) MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death