BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPATCH 2.5, BTH

    MDR report key: 20314943 · Received September 26, 2024

    Report

    Report Number
    2133409-2024-00059
    Event Type
    Injury
    Date Received
    September 26, 2024
    Report Date
    September 26, 2024
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    77226495
    PMA / PMN Number
    K081444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A 2ND DEGREE BURN FROM EPATCH. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE SENSOR WAS INSPECTED FOR GENERAL PHYSICAL INTEGRITY AND FOUND IN GOOD CONDITION. THE DEVICE WAS HEAT STRESSED TESTED AND AFTER THE 1.5-HOUR TESTING, THE MAXIMUM TEMPERATURE REACHED WAS 82.6F. NO PROBLEMS WERE FOUND. ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED ON THE PATCH AS IT IS SINGLE USE AND WAS NOT RETURNED. ALLEGATION IS CONFIRMED THROUGH IMAGES OF PATIENT SKIN IRRITATION ATTACHED TO THIS CASE OR A PRESCRIPTION FROM A MEDICAL PROFESSIONAL AND IS MOST PROBABLE TO BE A BIO-INCOMPATIBILITY ISSUE WITH THE ELECTRODE ADHESIVE AND/OR HYDROGEL COMPONENTS. ENGINEERING COULD NOT REPLICATE THE ALLEGATION OF THE SENSOR OVERHEATING. SENSOR PASSED VISUAL AND FUNCTIONAL TESTING. ALL TESTING OF THE SENSOR COULD NOT PROVIDE EVIDENCE FOR AN OVERHEAT OF THE DEVICE TO CAUSE A BURN TO THE PATIENT. ROOT CAUSE IS MORE PROBABLE TO BE A BIO-INCOMPATIBILITY ISSUE WITH THE ELECTRODE ADHESIVE AND/OR HYDROGEL COMPONENTS CONSIDERING THERE IS NO EVIDENCE OF A THERMAL EVENT. MARSI, SKIN BURN, AND ASSOCIATED SYMPTOMS MAY INHERENTLY OCCUR UNDER THE COURSE OF ECG MONITORING. NO SINGLE FACTOR OR COMBINATION OF FACTORS CAN BE ATTRIBUTABLE TO ELECTRODE SKIN IRRITATION AND ASSOCIATED SYMPTOMS. THE PRODUCT LABELING ADVISES PATIENTS 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) 2024 THAT THE PATIENT HAD A 2ND DEGREE BURN FROM THE EPATCH. THE PATIENT REPORTED BLISTERING AND WELTS. ORIGINALLY THE PATIENT USED OVER THE COUNTER HYDROCORTISONE ANTIBIOTIC OINTMENT. LATER ON (B)(6) 2024, THE PATIENT WENT TO URGENT CARE WHERE THE PATIENT WAS DIAGNOSED WITH A 2ND DEGREE BURN. THE PATIENT WAS RECOMMENDED TO KEEP THE AREA CLEAN AND DRY AND COVER THE BURN FOR PROTECTION. THE PATIENT WAS ALSO TOLD TO KEEP PUTTING THE ANTIBIOTIC OINTMENT ON. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREP AND DID NOT HAVE A HISTORY OF SKIN SENSITIVITIES/ALLERGIES HOWEVER, DID HAVE AN ALLERGY TO METALS AND ADHESIVES. THE PATIENT DID NOT TAKE A BREAK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491795 EPATCH 2.5, BTH EPATCH SENSOR - 2.5 DSI BRAEMAR MANUFACTURING, LLC 02-02045 77226495

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Required Intervention