BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-FILLED MAMMARY PROSTHESIS

    MDR report key: 2926216 · Received January 15, 2013

    Report

    Report Number
    1645337-2013-00003
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    July 25, 2012
    Report Date
    January 15, 2013
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21681 GEL-FILLED MAMMARY PROSTHESIS BREAST IMPLANT FTR MENTOR 5546293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention