BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN

    MDR report key: 3895999 · Received June 20, 2014

    Report

    Report Number
    MW5036799
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 19, 2014
    Manufacturer
    INAMED
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    L BREAST IMPLANTED LARGE CELL LYMPHOMA, S/P L BREAST IMPLANT PLACEMENT IN 2003: IN 1998- AT (B)(6) DIAGNOSED WITH L BREAST CA AND L LUMPECTOMY WITH RADIATION DONE. IN 2002-L LATISSIMUS DORSI MYOCUTANEOUS FLAP RECONSTRUCTION WITH TISSUE EXPANDER (MENTOR REF#(B)(4), LOT #248391) AND R SUBQ MASTECTOMY WITH IMMEDIATE RECONSTRUCTION WITH SALINE IMPLANT (MENTOR REF#(B)(4), SILTEX CONTOUR PROFILE MAMM PROSTH LOT #251827, SN: (B)(4) ADDED 450ML TO IMPLANT) PATH REPORT ON (B)(6) 2002 WAS NEGATIVE FOR CARCINOMA IN EITHER BREAST. ON (B)(6)2013, SECOND STAGE RECONSTRUCTION L BREAST, EXPANDER REMOVED, MCGHAN 163 SALINE IMPLANT PLACED REF# (B)(4), SN: (B)(4), LOT #582791, 380CC, PRESENTED TO DR. (B)(6) (B)(6) 2014 WITH PAIN AND SWELLING IN L BREAST-GRADE IV CAPSULE CONTRACTURE NOTED. SHE DID NOT WISH TO SCHEDULE SURGERY AT THAT TIME. SECOND CONSULTATION ON (B)(6) 2014, NEW LUMP IN L BREAST, ULTRASOUND, MRI AND L BREAST BIOPSY DONE. ON (B)(6) 2014, REMOVED INTACT IMPLANT L BREAST (MCGHAN STYLE 163 SALINE TEXTURED IMPLANT), L TOTAL CAPSULECTOMY L BREAST. PATH REPORT SHOWS ALCL (ANAPLASTIC LARGE CELL LYMPHOMA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363112 MCGHAN SALINE IMPLANT FWM INAMED STYLE 163 582791

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O| R