BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ELECTRODE-PATCH

    MDR report key: 24578179 · Received March 12, 2026

    Report

    Report Number
    2133409-2026-00043
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 12, 2026
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2026, THE PATIENT CALLED REGARDING RECONNECTING THEIR MCOT DEVICE WITH UNIVERSAL PATCH CONFIGURATION AFTER A BREAK IN SERVICE (BIS) DUE TO SKIN IRRITATION. THE PATIENT EXPERIENCED GENERAL REDNESS, IRRITATION, ITCHING, RAISED SKIN, AND BLISTERS/WELTS WHILE USING THE DEVICE (ELECTRODE LOT # P203827). THE PATIENT SOUGHT MEDICAL TREATMENT FROM A DERMATOLOGIST WHO PRESCRIBED A NON-STEROID CREAM FOR THE IRRITATION.THE PATIENT CONFIRMED THEY HAD FOLLOWED THE RECOMMENDED SKIN PREPARATION STEPS. THE PATIENT HAS A DOCUMENTED HISTORY OF SKIN SENSITIVITY/ALLERGY TO LATEX ADHESIVES. THE PATIENT'S BREAK-IN-SERVICE LASTED APPROXIMATELY 5 DAYS. 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 HAS A DOCUMENTED HISTORY OF SKIN SENSITIVITY/ALLERGY TO LATEX ADHESIVES. 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 CALLED REGARDING RECONNECTING THEIR MCOT DEVICE WITH UNIVERSAL PATCH CONFIGURATION AFTER A BREAK IN SERVICE (BIS) DUE TO SKIN IRRITATION. THE PATIENT EXPERIENCED GENERAL REDNESS, IRRITATION, ITCHING, RAISED SKIN, AND BLISTERS/WELTS WHILE USING THE DEVICE (ELECTRODE LOT # P203827). THE PATIENT SOUGHT MEDICAL TREATMENT FROM A DERMATOLOGIST WHO PRESCRIBED A NON-STEROID CREAM FOR THE IRRITATION.THE PATIENT CONFIRMED THEY HAD FOLLOWED THE RECOMMENDED SKIN PREPARATION STEPS. THE PATIENT HAS A DOCUMENTED HISTORY OF SKIN SENSITIVITY/ALLERGY TO LATEX ADHESIVES. THE PATIENT'S BREAK-IN-SERVICE LASTED APPROXIMATELY 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637909 UNIVERSAL ELECTRODE-PATCH ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DRX BRAEMAR MANUFACTURING, LLC 02-01609 P203827

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Hospitalization