BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ELECTRODE-PATCH

    MDR report key: 22557442 · Received July 21, 2025

    Report

    Report Number
    2133409-2025-00057
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    July 11, 2025
    Report Date
    July 21, 2025
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DRX
    PMA / PMN Number
    K153473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, THE PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BLISTERS AND RED RASH WHILE UTILIZING THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNELS. THE PATIENT DID SEEK MEDICAL TREATMENT WAS PRESCRIBED MEDICATION. THERE IS NO REPORT THAT THE PATIENT TREATED WITH OVER-THE COUNTER MEDICATION. THE PATIENT DID TAKE A BREAK IN SERVICE FOR 3 DAYS. THE PATIENT DID FOLLOW INSTRUCTIONS FOR SKIN PREP AND DID NOT REPORT SKIN SENSITIVITY/ALLERGY TO ADHESIVES/METALS. 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. THE FOLLOWING FACTOR WAS IDENTIFIED AND/OR ATTRIBUTED TO ELECTRODE SKIN IRRITATION AND ASSOCIATED SYMPTOMS: AGE EXTREMES, AS THE PATIENT IS 2 YEARS OLD. 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

    ON (B)(6) 2025, THE PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BLISTERS AND RED RASH WHILE UTILIZING THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNELS. THE PATIENT DID SEEK MEDICAL TREATMENT AND WAS PRESCRIBED MEDICATION. THERE IS NO REPORT THAT THE PATIENT TREATED WITH OVER-THE COUNTER MEDICATION. THE PATIENT DID TAKE A BREAK IN SERVICE FOR 3 DAYS. THE PATIENT DID FOLLOW INSTRUCTIONS FOR SKIN PREP AND DID NOT REPORT SKIN SENSITIVITY/ALLERGY TO ADHESIVES/METALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784021 UNIVERSAL ELECTRODE-PATCH ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DRX BRAEMAR MANUFACTURING, LLC 02-01609

    Patients

    Seq Age Sex Outcome Treatment
    1 32 MO Female Hospitalization