BEUDAMED
    FDA Adverse Event Summary report: N

    MAMMARY PROSTHESIS

    MDR report key: 13488 · Received May 24, 1994

    Report

    Report Number
    MW1002187
    Date Received
    May 24, 1994
    Date of Event
    May 15, 1989
    Report Date
    May 13, 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 ACHES AND PAINS, BREAST HARDNESS, PAINFUL BREASTS, ITCHING, REDNESS AND SWELLING OF SKIN, SWOLLEN LYMPH NODES, SWELLING OF JOINTS AND HANDS, FATIGUE, UNUSUAL HAIR LOSS, RASHES, SHORTNESS OF BREATH, INFECTIONS, AND LOW BLOOD PRESSURE. (SAME RPTR REFERRED TO IN 1002184 - 1002186 AND 1002188.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMARY PROSTHESIS Implant FTR MENTOR CORP. 247 66, 270 83

    Patients

    Seq Age Sex Outcome Treatment
    1 * *