BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK SILICONE BREAST IMPLANT

    MDR report key: 13947 · Received June 13, 1994

    Report

    Report Number
    MW1002444
    Date Received
    June 13, 1994
    Date of Event
    January 1, 1984
    Report Date
    June 9, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD HER FIRST SET OF IMPLANTS REMOVED AND REPLACED BY THIS CO'S IMPLANTS. THESE ARE STILL IMPLANTED AND CAUSING HARDENING, CAPSULAR CONTRACTURE, NUMBNESS, PAIN AND SWELLING IN JOINTS, VERY SHARP PAIN (NEEDLE STICKING) IN BOTH BREASTS, FATIGUE, DIZZINESS, MENTAL CONFUSION ETC. (SAME RPTR REFERRED TO IN 1002443.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK SILICONE BREAST IMPLANT Implant FTR MEDICAL ENGINEERING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *