BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK

    MDR report key: 550611 · Received August 13, 2004

    Report

    Report Number
    MW1033047
    Event Type
    Injury
    Date Received
    August 13, 2004
    Date of Event
    August 1, 1984
    Report Date
    August 5, 2004
    Manufacturer
    *
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR'S FIRST INDICATION OF A NEUROLOGICAL PROBLEM WAS IN 1991. AT THAT TIME DIAGNOSIS= "PROBABLE MS." NO CONSIDERATION OF IMPLANTS. IN 1999 RPTR HAD THEIR FIRST AND ONLY MAMMOGRAM. AFTER THAT RPTR DEVELOPED RASHES, FATIGUE, PERIPHERAL (NEUROPATHY, HAD HIGH ANA (1:320) ANTI-SSA AND SMUTS ANTIBODIES, THYROID. RPTR HAS NOW BEEN DIAGNOSED WITH HASHIMOTO'S THYROIDITIS. CONNECTIVE TISSUE DISEASE, POSSIBLE LUPUS. MULTIPLE SCLEROSIS BASED ON BRAIN, CSPINE MRI AND SPINAL TAP. STAPH INFECTION IN RIGHT BREAST. IMPLANTS WERE RUPTURED. SILICONE HAD MIGRATED OUTSIDE OF AN INTACT CAPSULE. GIANT CELLS SHOWING IMMUNE RESPONSE FOUND ON OUTSIDE OF CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK SILICONE BREAST IMPLANT FTR * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| O| R| S