BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMI PORTABLE EEG

    MDR report key: 24210603 · Received January 29, 2026

    Report

    Report Number
    MW5183024
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    September 10, 2025
    Report Date
    January 23, 2026
    Manufacturer
    EPITEL, INC.
    Product Code
    OMC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NEAR THE END OF (B)(6) 2025 AND BEGINNING OF (B)(6) 2025. I WAS PRESCRIBE A PORTABLE EEG MONITORS. I HAD AN CONCERNING ALLERGIC REACTION TO THE ADHESIVE DESPITE IT BEING LISTED ON MY MEDICAL RECORDS AS AN ALLERGY AND INFORMING MY REPRESENTATIVE WITH THE COMPANY. AT THE TIME I WAS UNAWARE OF THE EXUBERANT MEDICAL BILL I WAS SENT SO I ONLY SEEKED URGENT CARE AID AND DID NOT TAKE PICTURE DOCUMENTATION OF THE ALLERGIC REACTION. HOWEVER, THE ALLERGIC REACTION CAUSE SYMPTOMS FROM BUMPS AND ITCHINESS TO SWELLING OF LYMPH NODES AND CHEST PAIN. I HAVE CONTACTED THE MANUFACTURER COMPANY ABOUT THIS SEVERAL TIMES AND RECEIVED NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268048 REMI PORTABLE EEG REDUCED- MONTAGE STANDARD ELECTROENCEPHALOGRAPH OMC EPITEL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Other BIRTH CONTROL.| DOXYCYCLINE HYCLATE.| HUMIRA.| IMMUNE SUPPLEMENT.| MIGRAINE SUPPLEMENT.