BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPATCH 2.5, BTH

    MDR report key: 23315797 · Received October 16, 2025

    Report

    Report Number
    2133409-2025-00123
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 16, 2025
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSH
    PMA / PMN Number
    K171410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025, THE PATIENT WAS EXPERIENCING A BURNING AND ITCHING SENSATION FROM ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL AND EPATCH SENSOR - 2.5. THE PATIENT REPORTED THAT THE BURNING AND ITCHING SENSATION WOKE THEM UP. THE PATIENT CALLED THEIR DOCTOR AND MADE AN APPOINTMENT SINCE THE BURN AND ITCHINESS WERE GETTING PROGRESSIVELY WORSE. THE PATIENT WAS DIAGNOSED A FIRST-DEGREE BURN AND WAS PRESCRIBED LIDOCAINE AND HISTAMINE. THE PATIENT DOES NOT KNOW IF THE SENSOR OVERHEATED SINCE THEY WERE SLEEPING AT THE TIME OF THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665894 EPATCH 2.5, BTH EPATCH SENSOR - 2.5 DSH BRAEMAR MANUFACTURING, LLC 02-02045

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention ELECTRODE - PATCH - UNIVERSAL 2 CHANNELS, (B)(6).