BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK MEDICAL ENGINEERING CORP.

    MDR report key: 549567 · Received July 11, 2004

    Report

    Report Number
    MW1032669
    Event Type
    Injury
    Date Received
    July 11, 2004
    Date of Event
    August 15, 1990
    Report Date
    July 11, 2004
    Manufacturer
    SURGITECK, MEDICAL ENGINEERING CORP
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD DOUBLE LUMEN BREAST IMPLANTS PUT IN. IN 2000 BECAME EXTREMELY ILL. MULTIPLE PROBLEMS OF SILICONE TOXICITY. FIBROMYALGIA DIAGNOSED, SEVERE HEADACHES, NEUROLOGICAL PROBLEMS, COULDN'T WALK ANYMORE, HEARING AFFECTED, VISION AFFECTED, MIGRAINES, MEMORY PROBLEMS, SWELLING IN JOINTS, PAIN IN JOINTS, HYPOTHYROIDISM, FUNGUS INFECTIONS ON FEET, EXTREME, PSYCHIATRIC DISORDERS, FEELINGS OF SUICIDE, DEPRESSION, PANIC ANXIETY, IRRITABLE BOWEL, CHRONIC CONSTIPATION, LATER WENT TO CONTINUOUS DIARRHEA, RADIATING PAIN, CASCADING FIBROMYALGIA PAIN, COULDN'T STAND, SEIZURES. NOT UNTIL 2003, DID PT REALIZE IT WAS THE BREAST IMPLANTS. PT HAD THEM OUT. THERE WERE TWO BILATERAL EXTRACAPSULAR RUPTURES, INTRA AND EXTRACAPSULAR RUPTURES. PT STILL NEEDS TO FIND OUT IF IT IS ALL OUT OF THEM. PT IS PERMANENTLY DISABLED AS A RESULT OF THIS INJURY AND RECEIVE DISABILITY FOR BIPOLAR DISORDER, SILICONE TOXICITY AND FIBROMYALGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MEDICAL ENGINEERING CORP. BREAST IMPLANT DOUBLE LUMEN FTR SURGITECK, MEDICAL ENGINEERING CORP RD GEL/SAL Q-S 240CC 2626000S12 75707-88A
    2 SURGITEK MEDICAL ENGINEERING CORP. BREAST IMPLANT DOUBLE LUMEN FTR SURGITECK, MEDICAL ENGINEERING CORP RD GEL/SAL Q-S 240CC 2626500S12 21002-87D

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| S