BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE MAMMARY PROSTHESIS

    MDR report key: 17789 · Received November 16, 1994

    Report

    Report Number
    MW1004042
    Date Received
    November 16, 1994
    Report Date
    November 8, 1994
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 1/14/83 RPTR HAD A BILATERAL BREAST RECONSTRUCTION WITH LATISSIMUS DORSI MUSCLE FLAPS AND THESE IMPLANTS TO REPLACE ANOTHER CO'S IMPLANTS. ON 9/20/83 SHE HAD RELEASE OF AXILLARY SCARS WITH Z-PLASTIES AND EXCISION OF MAMMARY CAPSULE RIGHT BREAST. THE RIGHT IMPLANT WAS REMOVED AND RE-INSERTED.ON 1/13/86 SHE HAD REMOVAL OF THE IMPLANTS, CULTURE OF BREAST POCKETS AND INJECTION OF HYPERTROPHIC RIGHT SHOULDER SCARS. THE RIGHT BREAST SHOWED A VERY THIN CAPSULE OVERLYING THE IMPLANT WHICH WAS JUST BELOW THE SKIN SURFACE. SHE ALSO COMPLAINS OF THE FOLLOWING: LOSS OF MUSCLE COORDINATION, VISION PROBLEMS, HERNIA, BREAST TENDERNESS, SKIN HARDENING AND TIGHTNESS, COLDNESS/PAIN OF EXTREMITIES, MALPOSITIONED IMPLANTS, IMPLANT HARDNESS AND INFECTIONS, CAPSULECTOMIES, DOUBLE VISION, DIZZINESS, VISUAL DISTURBANCE, JOINT SWELLING, PAIN, STIFFNESS IN AM IN SOME JOINTS AND FEET, ARTHRITIS SYMPTOMS IN FINGERS, THUMBS, RIGHT KNEE AND SHOULDER, POSSIBLE MULTIPLE SCLEROSIS, FATIGUE, PERIPHERAL WEAKNESSES, NUMBNESS, ARTHRITIS RIGHT KNEE, NIPPLE DISCHARGE, FOREIGN BODY GIANT CELL REACTION, MILD PARETHESIAS, COLDS, UPPER RESPIRATORY INFECTIONS, BREAST HEMATOMAS, HEADACHES, FACIAL TINGLING, FAINTING, SLEEPING PROBLEMS, FIBROMYOSITIS. (ALSO SEE 100402.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE MAMMARY PROSTHESIS Implant BREAST IMPLANT FTR V. MUELLER DIV. BAXTER HEALTHCARE CORP. STYLE 7000 ROUND 221620

    Patients

    Seq Age Sex Outcome Treatment
    1 *