BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA ECHO LX K 15

    MDR report key: 305821 · Received November 21, 2000

    Report

    Report Number
    2183553-2000-00015
    Event Type
    Injury
    Date Received
    November 21, 2000
    Date of Event
    October 31, 2000
    Report Date
    November 20, 2000
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    LNH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GEMS THAT A PT WITH LARGE TATTOOS COMPLAINED OF A BURNING SENSATION COMING FROM THE AREA UNDER THEIR TATTOOS. THE PT LATER EXPERIENCED A RAISING OF THE SKIN. IT IS STATED IN THE USER MANUAL, BEFORE SCANNING, WARN PATIENTS WITH PERMANENT EYELINER OR OTHER METALLIC INK TATTOOS ABOUT THE RISK OF SKIN IRRITATION. THE PRESENCE OF THE TATTOOS WAS NOT BROUGHT TO THE ATTENTION OF THE TECH BEFORE THE EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA ECHO LX K 15 MAGNETIC RESONANCE LNH GE MEDICAL SYSTEMS 2226300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other