BEUDAMED
    FDA Adverse Event Summary report: N

    MAMMARY IMPLANT

    MDR report key: 17747 · Received November 15, 1994

    Report

    Report Number
    MW1004031
    Date Received
    November 15, 1994
    Report Date
    November 8, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 5/14/75, RPTR HAD BILATERAL BREAST BIOPSIES AND AUGMENTATION USING THIS CO'S 175 CC LEFT TEAR DROP AND 200 CC RIGHT ROUND IMPLANTS. SHE HAS HYPOMASTIA, PTOSIS, AND NODULARITIES OF BREASTS. DIAGNOSIS: FIBROCYSTIC DISEASE OF THE BREASTS. UNREADABLE IMPLANT NUMBERS. ON 12/7/78, SHE HAD EXCISION OF MARGINS AND TWO LAYER CLOSURE WITH RELAXING INCISION OF LEFT BREAST CAPSULE POSTERIORLY. SHE COMPLAINS OF ULCERATION FOR ONE WEEK UNDER LEFT BREAST AND 1 1/2 TO 3 CM EXPOSING IMPLANT. ON 2/20/79, SHE HAD REMOVAL OF LEFT PROSTHESIS. SHE ALSO COMPLAINS OF BREAST DRAINAGE AND SWELLING, ALLERGIC DERMATITIS, FATIGUE, RHEUMATOID ARTHRITIS, SYMMETRICAL POLYARTHRITIS, SYNOVIAL SWELLING AND TENDER JOINTS, ARTHRALGIAS AND MYALGIAS, IMPLANT LEAKAGE, MUSCLE FATIGUE, GENERAL ACHING AND STIFFNESS. (ALSO SEE 1004032.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMARY IMPLANT Implant BREAST IMPLANT FTR DOW CORNING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *