BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNI TRAK MRI NON-INVASIVE MONITORING SYSTEM

    MDR report key: 29312 · Received December 13, 1995

    Report

    Report Number
    29312
    Event Type
    Other
    Date Received
    December 13, 1995
    Date of Event
    December 6, 1995
    Report Date
    December 11, 1995
    Manufacturer
    VERMONT MEDICAL, INC.
    Product Code
    MLN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD MRI SCAN OF LUMBAR SPINE WITH MONITORED ANESTHESIA. POST SCAN PT HAD THREE QUARTER-SIZE THIRD DEGREE BURNS WHERE MONITOR PATCHES HAD BEEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI TRAK MRI NON-INVASIVE MONITORING SYSTEM VERMED MONITOR PATCHES MLN VERMONT MEDICAL, INC. 3100, VM R050

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other