BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ELECTRODE-PATCH

    MDR report key: 24679933 · Received March 24, 2026

    Report

    Report Number
    2133409-2026-00048
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 14, 2026
    Report Date
    March 24, 2026
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2026 THE PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BLISTERS/WELTS WHILE USING AN MCOT DEVICE WITH THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL CONFIGURATION (ELECTRODE LOT # P203767). THE PATIENT SOUGHT MEDICAL TREATMENT FOR THE SKIN IRRITATION AND WAS PRESCRIBED CREAM BY THEIR HEALTHCARE PROVIDER. DUE TO THE SKIN IRRITATION, THE PATIENT DISCONTINUED USE OF THE DEVICE DESPITE NOT HAVING REACHED THEIR END OF SERVICE (EOS) DATE. THE PATIENT CONFIRMED THEY HAD FOLLOWED THE RECOMMENDED SKIN PREPARATION STEPS AND REPORTED NO HISTORY OF SKIN SENSITIVITY OR ALLERGIES. ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED AS THE UNIVERSAL ELECTRODE PATCH WAS NOT RETURNED. THE UNIVERSAL PATCH IS SINGLE USE AND DISPOSED AFTER USE; THEREFORE, IT IS NOT LIKELY TO BE RETURNED. ANY SKIN IRRITATION IS MOST PROBABLE TO BE A BIO-INCOMPATIBILITY ISSUE WITH THE ELECTRODE ADHESIVES. MEDICAL ADHESIVE RELATED SKIN INJURY (MARSI) IS LIKELY RELATED TO A BIOCOMPATIBILITY HAZARD MANIFESTING AT THE ELECTRODE'S INTERFACE WITH THE PATIENT'S SKIN. THE FOLLOWING FACTOR WAS IDENTIFIED AND/OR ATTRIBUTED TO ELECTRODE SKIN IRRITATION AND ASSOCIATED SYMPTOMS. THE PATIENT IS ELDERLY AND OVER 65 YEARS OLD. THE PRODUCT LABELING ADVISED PATIENT OF ALTERNATE OPTIONS AND OTHER STEPS TO TAKE IF SKIN IRRITATION DEVELOPS, INCLUDING HEALTHCARE PROFESSIONAL CONTACT AS NEEDED.

    Description of Event or Problem · 0

    ON (B)(6) 2026 THE PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BLISTERS/WELTS WHILE USING AN MCOT DEVICE WITH THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL CONFIGURATION (ELECTRODE LOT # P203767). THE PATIENT SOUGHT MEDICAL TREATMENT FOR THE SKIN IRRITATION AND WAS PRESCRIBED CREAM BY THEIR HEALTHCARE PROVIDER. DUE TO THE SKIN IRRITATION, THE PATIENT DISCONTINUED USE OF THE DEVICE DESPITE NOT HAVING REACHED THEIR END OF SERVICE (EOS) DATE. THE PATIENT CONFIRMED THEY HAD FOLLOWED THE RECOMMENDED SKIN PREPARATION STEPS AND REPORTED NO HISTORY OF SKIN SENSITIVITY OR ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740344 UNIVERSAL ELECTRODE-PATCH ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DRX BRAEMAR MANUFACTURING, LLC 02-01609 P203767

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization