BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOW CORNING BREAST IMPLANTS

    MDR report key: 1160907 · Received September 16, 2008

    Report

    Report Number
    MW5008291
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    June 1, 2008
    Report Date
    September 16, 2008
    Manufacturer
    DOW CORNING
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTS THAT SHE HAD AN MRI DONE IN 2008, AND IT REVEALED THAT THERE WAS A POCKET OF FLUID BEHIND THE RIGHT IMPLANT. PT STATES SHE TRIED TO FIND SOMEONE WHO WOULD TAKE HER INSURANCE, AND WHEN SHE DID, THE DR WAS OUT OF NETWORK AND HER INSURANCE DID NOT PAY ENOUGH. RPTR STATES THAT HER INSURANCE HAS DROPPED HER BECAUSE SHE IS OVER RESOURCES AND THE SURGERY WAS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOW CORNING BREAST IMPLANTS BREAST IMPLANTS SILICONE FTR DOW CORNING

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR