BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEG LEAD

    MDR report key: 7027798 · Received November 13, 2017

    Report

    Report Number
    MW5073326
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    November 8, 2017
    Report Date
    November 10, 2017
    Manufacturer
    UNK
    Product Code
    IKD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MRI PERFORMED ON PATIENT WITH MRI CONDITION EEG LEADS. MRI UNSAFE LEAD/WIRE, IDENTICAL IN GAUGE, WOUND IN WITH MRI CONDITIONAL LEADS AND ATTACHED TO PATIENT CHEST CAUSING A BURN ON PATIENT CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803223 EEG LEAD EEG LEAD IKD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other