BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLICON

    MDR report key: 21908 · Received May 19, 1995

    Report

    Report Number
    MW1006011
    Event Type
    Injury
    Date Received
    May 19, 1995
    Date of Event
    September 24, 1990
    Report Date
    March 16, 1995
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADVERSE REACTION TO SILICONE BREAST IMPLANTS-SEVERE ALLERGIC REACTION CAUSE UNKNOWN. 2/91, GRADUAL DECLINE IN GENERAL HEALTH SINCE THAT TIME. THESE IMPLANTS WERE USED FOR RECONSTRUCTION AFTER BILATERAL MASTECTOMY IN 7/90. NO CANCER- SEVERE FYBROCYSTIC BREAST DISEASE. 3/95- DIAGNOSED WITH INDUCED LUPUS, USUALLY SEEN AS A RESULT OF DRUGS; RPTR IS TAKING NO DRUGS THAT HAVE THIS SIDE EFFECT. EXPLANT RECOMMENDED. RPTR HAS HAD THE SYMPTOMS OF LUPUS SINCE 2/91 & THEY HAVE CONTINUED TO WORSEN. SHE ALSO HAS FIBROMYALGIA, ASTHMA SINCE 9/94, HIGH BLOOD PRESSURE SINCE 7/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLICON Implant POLYURETHANE COVERED SILICON BREAST FTR MEDICAL ENGINEERING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention| S EXPLANT RECOMMENDED.| THERAPY FOR FATIGUE, JOINT & MUSCLE PAIN.