BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ELECTRODE-PATCH

    MDR report key: 24711230 · Received March 30, 2026

    Report

    Report Number
    2133409-2026-00053
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 21, 2026
    Report Date
    March 27, 2026
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6), THE PATIENT REPORTED SKIN IRRITATION WHILE USING AN MCOT DEVICE WITH THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL CONFIGURATION (ELECTRODE LOT # P203785). THE IRRITATION WAS DESCRIBED AS PEELING AND BLISTERS/WELTS. THE PATIENT SOUGHT MEDICAL TREATMENT FOR THE SKIN IRRITATION AND WAS PRESCRIBED A TOPICAL STEROID MEDICATION. THE PATIENT DISCONNECTED THE DEVICE DUE TO THE SKIN IRRITATION. THE PATIENT CONFIRMED THAT SKIN PREPARATION STEPS WERE FOLLOWED CORRECTLY, AND THERE IS NO HISTORY OF SKIN SENSITIVITY OR ALLERGIES. A BIS PAUSE WAS IMPLEMENTED FROM (B)(6) 2026, AND THE END OF SERVICE (EOS) DATE WAS CHANGED TO (B)(6) 2026. THE PATIENT INDICATED THEY WOULD DISCUSS WITH THEIR CARDIOLOGIST BEFORE MAKING A FINAL DECISION REGARDING EARLY DISCONNECTION OR CONTINUING THE BREAK IN SERVICE. 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 WHILE USING AN MCOT DEVICE WITH THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL CONFIGURATION (ELECTRODE LOT # P203785). THE IRRITATION WAS DESCRIBED AS PEELING AND BLISTERS/WELTS. THE PATIENT SOUGHT MEDICAL TREATMENT FOR THE SKIN IRRITATION AND WAS PRESCRIBED A TOPICAL STEROID MEDICATION. THE PATIENT DISCONNECTED THE DEVICE DUE TO THE SKIN IRRITATION. THE PATIENT CONFIRMED THAT SKIN PREPARATION STEPS WERE FOLLOWED CORRECTLY, AND THERE IS NO HISTORY OF SKIN SENSITIVITY OR ALLERGIES. A BIS PAUSE WAS IMPLEMENTED FROM (B)(6) 2026, AND THE END OF SERVICE (EOS) DATE WAS CHANGED TO (B)(6) 2026. THE PATIENT INDICATED THEY WOULD DISCUSS WITH THEIR CARDIOLOGIST BEFORE MAKING A FINAL DECISION REGARDING EARLY DISCONNECTION OR CONTINUING THE BREAK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772451 UNIVERSAL ELECTRODE-PATCH ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DRX BRAEMAR MANUFACTURING, LLC 02-01609 P203785

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization