BEUDAMED
    FDA Adverse Event Summary report: N

    MENTOR WORLDWIDE LLC

    MDR report key: 1934213 · Received December 13, 2010

    Report

    Report Number
    1645337-2010-00036
    Date Received
    December 13, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MENTOR WORLDWIDE, LLC
    Product Code
    MRD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MENTOR REP STATED IN VOICEMAIL THAT THE SIZE AND PROFILE WERE NOT STAMPED ON A "400 HP SMOOTH GEL" IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR WORLDWIDE LLC SALINE-FILLED MAMMARY PROSTHESES MRD MENTOR WORLDWIDE, LLC 6408659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other