BEUDAMED
    FDA Adverse Event Summary report: N

    SALINE-FILL MAMMARY IMPLANT, 240 CC

    MDR report key: 16543 · Received October 3, 1994

    Report

    Report Number
    MW1003569
    Date Received
    October 3, 1994
    Report Date
    September 28, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINED OF FATIGUE, SLEEPLESSNESS, STIFFNESS, MUSCULOSKELETAL PAIN, RAYNAUD'S, DECREASED STAMINA, DRY EYES AND MOUTH, NUMBNESS AND TINGLING IN FINGERS. INCREASED LYMPH NODES IN ARM PITS AND NECK, PERSONALITY CHANGES, SHE IS IRRITABLE AND MOODY, OCCASIONALLY DEPRESSED, HAD MEMORY PROBLEMS, ATYPICAL CONNECTIVE TISSUE DISEASE/RHEUMATIC SYNDROME/NON-SPECITIC AUTOIMMUNE CONDITION, CAPSULAR CONTRACTURES, HEADACHES, NERVOUSNESS, BREAST TENDERNESS, MUSCLE FATIGUE, SWELLING OF HANDS AND FINGERS, COLD FEET AND HANDS, VISIBLE IMPLANT WRINKLES, WEIGHT GAIN, CAN'T HOLD ARMS OVER HEAD AND CHEST AND SHOULDER PAIN. (ALSO SEE 1003567, 1003568)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE-FILL MAMMARY IMPLANT, 240 CC Implant FWM MCGHAN MEDICAL CORP. STYLE 168

    Patients

    Seq Age Sex Outcome Treatment
    1 *