BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOPER REPLICON MAMMARY IMPLANT

    MDR report key: 36749 · Received September 3, 1996

    Report

    Report Number
    2182596-1996-00004
    Event Type
    Injury
    Date Received
    September 3, 1996
    Report Date
    August 19, 1996
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGATIONS OF SCLERODERMA LIKE SYNDROME, ATYPICAL CONNECTIVE TISSUE DISEASE, ATYPICAL NEUROLOGIC DISEASE, RHEUMATOID ARTHTRITIS, DERMATOMYOSITIS, SJOGREN'S SYNDROME, NONSPECIFIC AUTOIMMUNE CONDITION, POLYARTHRITIS, KERATOCONJUNCTIVITIS SICCA, MYALGIAS, NEUROPSYCHIATRIC, PERIPHERAL NEUROPATHY, CHRONIC FATIGUE, ALOPECIA, SLEEP DISTURBANCES, DIZZINESS, COLITIS OR BOWEL IRRITABILITY, CHRONIC INFLAMMATORY RESPONSE, BREAST INFECTION, DISFIGUREMENT, IMPAIRMENT OF THE IMMUNE SYSTEM, COMPLEX SURGICAL PROCEDURES, SCAR TISSUE CAPSULATION, AUTOIMMUNE DISEASE, MEMORY LOSS, SKIN DISCOLORATION, LOSS OF CONCENTRATION, HUMAN ADJUVANT DISEASE, DEPRESSION, SILICONE TOXITY SYNDROME, SILICONE IMPLANT DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOPER REPLICON MAMMARY IMPLANT Implant POLYURETHANE-COVERED MAMMARY IMPLANT FTR MEDICAL ENGINEERING CORP. RE3-175 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention