BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ELECTRODE-PATCH

    MDR report key: 23031003 · Received September 11, 2025

    Report

    Report Number
    2133409-2025-00086
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 11, 2025
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DRX
    PMA / PMN Number
    K153473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT EXPERIENCED SKIN IRRITATION WHILE WEARING THE UNIVERSAL ELECTRODE PATCH. THE PATIENT'S SKIN IRRITATION CONSISTED OF HIVES. THE PATIENT DID SEEK MEDICAL ATTENTION ABOUT THE SKIN IRRITATION AND WAS PRESCRIBED A PRESCRIPTION STEROID. ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED AS THE UNIVERSAL ELECTRODE PATCH WAS NOT RETURNED. THE UNIVERSAL PATCH IS FOR SINGLE USE AND IS DISPOSED AFTER USE; THEREFORE, IT IS NOT LIKELY TO BE RETURNED. THE PATIENT FOLLOWED INSTRUCTIONS FOR SKIN PREPARATIONS AND DOES NOT HAVE AN ALLERGY OR SENSITIVITY TO METALS OR ADHESIVES. ANY SKIN IRRITATION IS 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. NO SINGLE FACTOR OR COMBINATION FACTORS WERE IDENTIFIED AND/OR ATTRIBUTE TO ELECTRODE SKIN IRRITATION AND ASSOCIATED SYMPTOMS. THE PRODUCT LABELING ADVISED THE 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

    IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT EXPERIENCED SKIN IRRITATION WHILE WEARING THE UNIVERSAL ELECTRODE PATCH. THE PATIENT'S SKIN IRRITATION CONSISTED OF HIVES. THE PATIENT DID SEEK MEDICAL ATTENTION ABOUT THE SKIN IRRITATION AND WAS PRESCRIBED A PRESCRIPTION STEROID. THE PATIENT DID TAKE A BREAK IN SERVICE FROM WEARING THE PATCH WHEN EXPERIENCED THE SKIN IRRITATION. THE PATIENT FOLLOWED INSTRUCTIONS FOR SKIN PREPARATIONS AND DOES NOT HAVE AN ALLERGY OR SENSITIVITY TO METALS OR ADHESIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192067 UNIVERSAL ELECTRODE-PATCH ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DRX BRAEMAR MANUFACTURING, LLC 02-01609 P203446

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention| H