BEUDAMED
    FDA Adverse Event Summary report: N

    CENTERGRAFT SENIX HF MAMMOGRAM MACHINE

    MDR report key: 32744 · Received May 7, 1996

    Report

    Report Number
    MW1009039
    Date Received
    May 7, 1996
    Date of Event
    May 11, 1992
    Report Date
    April 30, 1996
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    IZH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR WENT TO RADIOLOGY CTR FOR MAMMOGRAM. HER BREASTS ARE LARGE SO THEY USE A LOT OF COMPRESSION. THE PROBLEM IS THAT THE BREAST TISSUE CAN TAKE A LOT OF COMPRESSION BUT THE PECTORALIS MAJOR MUSCLES, UNDER THE ARMS CANNOT TAKE THAT MUCH COMPRESSION. THE PECTORALIS MAJOR MUSCLES WERE SPRAINED SO BAD THAT 4 YRS LATER SHE STILL HAS SPASMS WHICH DISABLED HER SO SHE CANNOT WORK AS A HAIR STYLIST OR ANYTHING. THIS PROCEDURE MUST BE CHANGED AND ANOTHER WAY TO X-RAY THE ARM PIT SHOULD BE FOUND. IN THE TECH'S REPORT, SHE LIES ABOUT WHY RPTR WAS CRYING. SHE SAYS RPTR WAS CRYING BECAUSE SHE THOUGHT SHE HAD CANCER OF RIGHT BREAST, RPTR TOLD HER SHE WAS CRYING BECAUSE IT HURT. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTERGRAFT SENIX HF MAMMOGRAM MACHINE MAMMOGRAPHIC X-RAY SYSTEM IZH GENERAL ELECTRIC CO. 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR