BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEMORYGEL MAMMARY PROSTHESIS

    MDR report key: 2001742 · Received February 14, 2011

    Report

    Report Number
    1645337-2011-00006
    Event Type
    Other
    Date Received
    February 14, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MENTOR WORLDWIDE, LLC.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PT WAS IMPLANTED WITH BILATERAL BREAST IMPLANTS DURING A BREAST RECONSTRUCTION PROCEDURE. PER A CLINICAL STUDY POST OPERATIVE REPORT FROM THE PT, SHE SUBSEQUENTLY WAS DIAGNOSED WITH NON-HODGKINS LYMPHOMA. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMORYGEL MAMMARY PROSTHESIS BREAST IMPLANT FTR MENTOR WORLDWIDE, LLC. 5742245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other