BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK GEK MAMMARY IMPLANT

    MDR report key: 79569 · Received March 31, 1997

    Report

    Report Number
    2182596-1997-00133
    Event Type
    Injury
    Date Received
    March 31, 1997
    Report Date
    March 11, 1997
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ALLEGATIONS OF DAMAGE TO THE IMMUNE SYSTEM, LOCAL AND SYSTEMIC INFLAMATORY RESPONSE, DISFIGUREMENT, CAPSULAR CONTRACTURE, REPEAT SURGERIES, BREAST NUMBNESS AND PAIN, FLU-LIKE SYMPTOMS, AXILLARY PAIN, SWOLLEN GLANDS, DEBILITATING FATIGUE AND HEADACHES, MYALGIA AND MUSCLE WEAKNESS, ARTHRALGIA AND JOINT SWELLING AND PAIN, MULTIPLE NEUROPATHIES, BLADDER INFECTIONS AND FREQUENT URINATION, PHOTOSENSITIVITY, BURNING PAIN IN BILATERAL AXILLARY AREAS, RASHES ON BREASTS, BURNING SENSATION IN STOMACH, HAIR LOSS, EASY "BRUISABILITY," NIGHT SWEATS, SLEEP DISTURBANCES, COLOR CHANGES IN FEET, VISION CHANGES, SICCA SYMPTOMS, PSEUDOMYOCARDIAL INFARCTIONS SYMPTOMS, POISONING BY SILICONE SILICA, FOREIGN BODY REACTIONS, COGNITIVE DYSFUNCTION IN THE FORM OF MEMORY LOSS, MENTAL CONFUSION AND DECREASED ABILITY TO CONCENTRATE, CAUSED BY BRAINDAMAGE OR ORGANIC BRAIN DYSFUNCTION AND A GENERAL FEELING OF BEING WEAK AND TIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK GEK MAMMARY IMPLANT Implant GEL MAMMARY IMPLANT FTR MEDICAL ENGINEERING CORP. 133100000 13598-87C,12544-87C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention