BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN 420 CC BREAST IMPLANTS (RIGHT & LEFT)

    MDR report key: 3170177 · Received June 13, 2013

    Report

    Report Number
    MW5030532
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    March 8, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MCGHAN MED CORP
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED ON BEHALF OF A PT WHO WAS DIAGNOSED WITH ALCL. THE PT PRESENTED WITH ANAPLASTIC LARGE CELL LYMPHOMA, DIAGNOSED ON (B)(6) 2013. HISTORY OF HODGKIN'S LYMPHOMA DIAGNOSED (B)(6) 2011. THESE TWO EVENTS CAME ABOUT AFTER THE PT UNDERWENT BREAST AUGMENTATION IN 1994. THIS REPORT IS FILED IN RESPONSE TO THE FOLLOWING REPORT: WWW.FDA.GOV/MEDICALDEVICES/PRODUCTSANDMEDICALPROCEDURES/IMPLANTSANDPROSTHETICS/BREASTIMPLANT/UCM239995.HTM. IN 2010, PT PRESENTED WITH AN ABNORMAL MAMMOGRAM DONE ON (B)(6) 2010. BREAST PAIN, SKIN COLOR CHANGE, SKIN TEXTURE CHANGE, AND INFLOWING DIFFUSION FROM THE RIGHT BREAST UP TO RIGHT NECK AND SHOULDER. THE PT WAS RUNNING A FEVER THROUGHOUT THE ENTIRE PROCESS. AFTER AN MRI AND SUBSEQUENT TESTS, THE PT WAS DIAGNOSED WITH HODGKIN'S LYMPHOMA AND UNDERWENT MANTLE RADIATION. ON (B)(6) 2012, THE PT UNDERWENT SURGERY ESSENTIALLY FOR A BREAST MASS, BUT THE PT ALSO DESIRED A MASTECTOMY FOR REMOVAL OF RIGHT AND LEFT IMPLANTS AND CAPSULES. THE PATHOLOGY OF THE OPERATION SOON REPORTED THAT THE PT ALSO HAS ALCL; THE MASS HAD COME FROM THE LYMPHOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269008 MCGHAN 420 CC BREAST IMPLANTS (RIGHT & LEFT) SALINE BREAST IMPLANT FWM MCGHAN MED CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| O| R