BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL Y REPLICON SILICONE IMPLANT

    MDR report key: 13800 · Received June 6, 1994

    Report

    Report Number
    MW1002364
    Event Type
    Injury
    Date Received
    June 6, 1994
    Date of Event
    January 13, 1994
    Report Date
    May 20, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD ANOTHER CO'S SILICONE IMPLANTS REMOVED BECAUSE OF HARDENING, DISTORTION, AND PAIN. THE DR TOLD HER IT WAS THE WORST CASE OF CALCIFIED SCAR TISSUE HE HAD EVER SEEN. SHE HAD THIS CO'S IMPLANTS REMOVED 1/13/94 BECAUSE OF POOR HEALTH, CELL CHANGES, BALD SPOT ON HER HEAD, AND CHRONIC FATIGUE. SHE HAS A GOITER AND SYMPTOMS OF LUPUS SUCH AS CHRONIC FATIGUE AND DISABILITY. (SAME RPTR REFERRED TO IN 1002363.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL Y REPLICON SILICONE IMPLANT Implant SILICONE BREAST IMPLANT FTR MEDICAL ENGINEERING CORP. 727103, 727076

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R| S