BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-FILLED MAMMARY PROSTHESIS

    MDR report key: 2926387 · Received January 15, 2013

    Report

    Report Number
    1645337-2013-00005
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MENTOR TEXAS, INC.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE ALCL SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21879 GEL-FILLED MAMMARY PROSTHESIS BREAST IMPLANT FTR MENTOR TEXAS, INC. 5627854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention