BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ELECTRODE-PATCH

    MDR report key: 25147134 · Received May 12, 2026

    Report

    Report Number
    2133409-2026-00080
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2026 THE PATIENT REPORTED SKIN IRRITATION FROM WEARING THE EPATCH WITH THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL CONFIGURATION. THE IRRITATION WAS NOT REPORTED BECAUSE THE PATIENT REFUSED TO PROVIDE SPECIFIC DETAILS. THE PATIENT DID SEEK MEDICAL TREATMENT FOR THE SKIN IRRITATION AND SOUGHT THE USE OF PRESCRIBED MEDICATION TO TREAT THE SKIN IRRITATION.THE PATIENT DECLINED TO PROVIDE THE SPECIFIC NAME OF THE PRESCRIBED MEDICATION USED TO TREAT THE SKIN IRRITATION. DESPITE THE IRRITATION, THE PATIENT DID NOT REQUEST A BREAK IN SERVICE OR DISCONTINUATION OF MONITORING. THE PATIENT DID NOT CONFIRM THE FOLLOWING OF THE RECOMMENDED SKIN PREPARATION STEPS.THE PATIENT REPORTED REFUSED TO CONFIRM A HISTORY OF SKIN SENSITIVITY/ALLERGIES. THE UNIVERSAL PATCH WAS NOT RETURNED FOR EVALUATION. 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. NO SINGLE FACTOR OR COMBINATION FACTORS WERE IDENTIFIED AND/OR ATTRIBUTED TO ELECTRODE SKIN IRRITATION AND ASSOCIATED SYMPTOMS. 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 FROM WEARING THE EPATCH WITH THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL CONFIGURATION. THE IRRITATION WAS NOT REPORTED BECAUSE THE PATIENT REFUSED TO PROVIDE SPECIFIC DETAILS.THE PATIENT DID SEEK MEDICAL TREATMENT FOR THE SKIN IRRITATION AND SOUGHT THE USE OF PRESCRIBED MEDICATION TO TREAT THE SKIN IRRITATION.THE PATIENT DECLINED TO PROVIDE THE SPECIFIC NAME OF THE PRESCRIBED MEDICATION USED TO TREAT THE SKIN IRRITATION. DESPITE THE IRRITATION, THE PATIENT DID NOT REQUEST A BREAK IN SERVICE OR DISCONTINUATION OF MONITORING.THE PATIENT DID NOT CONFIRM THE FOLLOWING OF THE RECOMMENDED SKIN PREPARATION STEPS.THE PATIENT REPORTED REFUSED TO CONFIRM A HISTORY OF SKIN SENSITIVITY/ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97592 UNIVERSAL ELECTRODE-PATCH ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DRX BRAEMAR MANUFACTURING, LLC 02-01609

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Hospitalization