BEUDAMED
    FDA Adverse Event Summary report: N

    OPTIMAM BREAST IMPLANT, 400 CC

    MDR report key: 13808 · Received June 6, 1994

    Report

    Report Number
    MW1002368
    Date Received
    June 6, 1994
    Report Date
    June 1, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROBLEMS NOTED BY RPTR: CANCER OF LEFT BREAST, FIBROCYSTIC RIGHT BREAST, HYPERTENSION, NERVOUSNESS, TENSION HEADACHES, ANEMIA, CHEST, CHEST WALL AND BREAST SORENESS, TIGHT BREAST, RIGHT FOOT PAIN, RUN DOWN FEELING, GASTRITIS, CERVICAL SPINE DEGENERATIVE ARTHRITIS, SHOULDER PAIN, BRONCHITIS, FEVER, LEFT ARM PAIN, STIFFNESS, NECK PAIN, TENDONITIS, TENNIS ELBOW, VIRAL SYNDROME, NAUSEA, RIGHT KNEE PAIN, CAPSULAR CONTRACTURE, IMPLANT HARDENING, POSSIBLE IMPLANT LEAKAGE, LEFT LEG PAIN, LOW BACK PAIN, ARTHRITIS SYMPTOMS, LEFT ARM SWELLING, JOINT SWELLING, PAIN AND STIFFNESS IN KNEES, ELBOW, SHOULDERS AND LOWER BACK, MUSCLE FATIGUE, LEFT HAND AND UNDERARM SWELLING, RASHES IN BETWEEN BREASTS, BREAST TENDERNESS, FATIGUE, AND SHOULDER AND BACK COLDNESS. RPTR STATES IMPLANTS MOVED AND WERE MALPOSITIONED CONSTANTLY UNTIL THEY HARDENED. SHE HEARD NOISES FROM IMPLANTS AT FIRST, BUT DOESN'T ANYMORE. SHE HAD PAIN WITH THE FIRST SET OF IMPLANTS AND COULD NOT SLEEP AT NIGHT. SHE CAN'T TOLERATE PRESSURE ON HER CHEST. (SAME RPTR REFERRED TO IN 1002367.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMAM BREAST IMPLANT, 400 CC BREAST IMPLANT FTR MEDICAL ENGINEERING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *