BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ELECTRODE-PATCH

    MDR report key: 24321215 · Received February 12, 2026

    Report

    Report Number
    2133409-2026-00018
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 12, 2026
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT REPORTED SKIN IRRITATION ON (B)(6) 2026 WHILE USING AN MCOT DEVICE WITH UNIVERSAL PATCH CONFIGURATION WITH LOT NUMBER P203716. THE PATIENT EXPERIENCED A RASH WITH BLEEDING/DISCHARGE. THE PATIENT SOUGHT MEDICAL TREATMENT FOR THE SKIN IRRITATION AND WAS TREATED WITH MEDICATION, THOUGH IT IS UNKNOWN WHETHER THIS WAS PRESCRIPTION OR OVER-THE-COUNTER MEDICATION. THE PATIENT HAS A HISTORY OF SKIN SENSITIVITY, SPECIFICALLY ALLERGIES TO CERTAIN TYPES OF ADHESIVES AND METALS SUCH AS NICKEL. DESPITE FOLLOWING THE RECOMMENDED SKIN PREPARATION STEPS, THE PATIENT DISCONTINUED USE OF THE DEVICE DUE TO THE SKIN IRRITATION. THE PATIENT REMOVED THE DEVICE AND LATER REAPPLIED IT. A BREAK IN SERVICE (BIS) WAS IMPLEMENTED AND THE END OF SERVICE (EOS) DATE WAS UPDATED. 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. 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 HISTORY OF SKIN SENSITIVITY, SPECIFICALLY ALLERGIES TO CERTAIN TYPES OF ADHESIVES AND METALS SUCH AS NICKEL. THE PRODUCT LABELING ADVISED PATIENT OF ALTERNATIVE OPTIONS AND OTHER STEPS TO TAKE IF SKIN IRRITATION DEVELOPS, INCLUDING HEALTHCARE PROFESSIONAL CONTACT AS NEEDED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED SKIN IRRITATION ON (B)(6) 2026 WHILE USING AN MCOT DEVICE WITH UNIVERSAL PATCH CONFIGURATION WITH LOT NUMBER P203716. THE PATIENT EXPERIENCED A RASH WITH BLEEDING/DISCHARGE. THE PATIENT SOUGHT MEDICAL TREATMENT FOR THE SKIN IRRITATION AND WAS TREATED WITH MEDICATION, THOUGH IT IS UNKNOWN WHETHER THIS WAS PRESCRIPTION OR OVER-THE-COUNTER MEDICATION. THE PATIENT HAS A HISTORY OF SKIN SENSITIVITY, SPECIFICALLY ALLERGIES TO CERTAIN TYPES OF ADHESIVES AND METALS SUCH AS NICKEL. DESPITE FOLLOWING THE RECOMMENDED SKIN PREPARATION STEPS, THE PATIENT DISCONTINUED USE OF THE DEVICE DUE TO THE SKIN IRRITATION. THE PATIENT REMOVED THE DEVICE AND LATER REAPPLIED IT. A BREAK IN SERVICE (BIS) WAS IMPLEMENTED AND THE END OF SERVICE (EOS) DATE WAS UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380985 UNIVERSAL ELECTRODE-PATCH ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DRX BRAEMAR MANUFACTURING, LLC 02-01609

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female