BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE LOW PROFILE GEL-FILLED MAMMARY PROSTHESIS

    MDR report key: 17503 · Received November 8, 1994

    Report

    Report Number
    MW1003958
    Date Received
    November 8, 1994
    Report Date
    November 2, 1994
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CHEST PAIN, BREAST DISCOMFORT, ADHESIVE CAPSULITIS, MYALGIAS, CHRONIC TENDONITIS LEFT SHOULDER, CHRONIC SLEEP DISTURBANCE, CEREBRAL ANEURISM, SPASTICITY OF LEFT HAND, CHRONIC FATIGUE, IRRITABLE BOWEL, CHRONIC URINARY TRACT INFECTIONS, BLADDER HYPERIRRITABILITY, CHRONIC DEPRESSION, ARTERIOSLEROTIC HEART DISEASE, GRANULOMAS OR SILICONOUS, HIGH BLOOD PRESSURE, HEADACHES, ARTHRITIS SYMPTOMS IN SPINE, RIGHT KNEE, LEFT HAND, JOINT SWELLING, PAIN, STIFFNESS IN LEFT HAND, MUSCLE FATIGUE, RASHES, HAIR LOSS, COLD AND NUMB EXTREMITIES. (ALSO SEE 1003957.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE LOW PROFILE GEL-FILLED MAMMARY PROSTHESIS BREAST IMPLANT, 280 CC FTR V. MUELLER DIV. BAXTER HEALTHCARE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *