BEUDAMED
    FDA Adverse Event Summary report: N

    MAMMARY PROSTHESIS

    MDR report key: 13449 · Received May 23, 1994

    Report

    Report Number
    MW1002164
    Date Received
    May 23, 1994
    Date of Event
    September 7, 1989
    Report Date
    May 12, 1994
    Manufacturer
    MENTOR CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINS OF SCARRING CYSTS, BREASTS HAVE BECOME HARD, FATIGUE, ARMS AND JOINTS ACHE, AND PAIN IN BREASTS. (SAME RPTR REFERRED TO IN 1002165.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMARY PROSTHESIS Implant FTR MENTOR CORP. 34568

    Patients

    Seq Age Sex Outcome Treatment
    1 *