BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ELECTRODE-PATCH

    MDR report key: 25016315 · Received April 28, 2026

    Report

    Report Number
    2133409-2026-00074
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 28, 2026
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2026, THE MOTHER OF THE PATIENT REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES RELATED TO THE MCOT DEVICE WITH UNIVERSAL PATCH CONFIGURATION (ELECTRODE LOT #E648007). THE PATIENT HAD REMOVED THE DEVICE THE PREVIOUS DAY ((B)(6) 2026) AROUND 1PM WHEN THE SCHOOL NURSE CALLED THE MOTHER. THE PATIENT SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED TWO MEDICATIONS: TRIAMCINOLONE AND MUPIROCIN FOR THE SKIN IRRITATION. THE PATIENT DISCONTINUED USE OF THE DEVICE DUE TO THE SKIN REACTION. THE PATIENT DID NOT FOLLOW THE RECOMMENDED SKIN PREPARATION INSTRUCTIONS AND "JUST USED SCRUB PAD." THE PATIENT HAS NO HISTORY OF SKIN SENSITIVITY OR ALLERGIES TO METALS AND/OR ADHESIVES. 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. 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 FACTORS WERE IDENTIFIED AND/OR ATTRIBUTED TO ELECTRODE SKIN IRRITATION AND ASSOCIATED SYMPTOMS. THE PATIENT IS PEDIATRIC OF 14 YEARS OLD AND DID NOT FOLLOW THE RECOMMENDED SKIN PREPARATION INSTRUCTIONS AND "JUST USED SCRUB PAD." 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 MOTHER OF THE PATIENT REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES RELATED TO THE MCOT DEVICE WITH UNIVERSAL PATCH CONFIGURATION (ELECTRODE LOT #E648007). THE PATIENT HAD REMOVED THE DEVICE THE PREVIOUS DAY ((B)(6) 2026) AROUND 1PM WHEN THE SCHOOL NURSE CALLED THE MOTHER. THE PATIENT SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED TWO MEDICATIONS: TRIAMCINOLONE AND MUPIROCIN FOR THE SKIN IRRITATION. THE PATIENT DISCONTINUED USE OF THE DEVICE DUE TO THE SKIN REACTION. THE PATIENT DID NOT FOLLOW THE RECOMMENDED SKIN PREPARATION INSTRUCTIONS AND "JUST USED SCRUB PAD." THE PATIENT HAS NO HISTORY OF SKIN SENSITIVITY OR ALLERGIES TO METALS AND/OR ADHESIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54690 UNIVERSAL ELECTRODE-PATCH ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DRX BRAEMAR MANUFACTURING, LLC 02-01609 E648007

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Hospitalization| L| R| O