BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEPATCH MONITORING SYSTEM

    MDR report key: 23597980 · Received November 19, 2025

    Report

    Report Number
    MW5179085
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    November 7, 2025
    Report Date
    November 16, 2025
    Manufacturer
    REACTDX/MEDICOMP, INC.
    Product Code
    DRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON FRIDAY, OCTOBER 31 A 30-DAY HEART MONITOR FROM TELEPATCH REACT WAS ATTACHED TO MY CHEST AT (B)(6). ON MONDAY NOVEMBER 3 HIVES BEGAN APPEARING ON MY UPPER TORSO. BY NOVEMBER 5 THE HIVES COMPLETELY COVERED MY UPPER TORSO AND BEGAN MOVING DOWN MY LEGS. THE ITCHING WAS SO BAD I COULD NOT SLEEP. I REMOVED THE PATCH ON NOVEMBER 7 AND WAS GIVE A PREDNISONE PRESCRIPTION TO HEAL THE HIVES OUTBREAK, WHICH WAS SUCCESSFUL. I MAILED BACK THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023829 TELEPATCH MONITORING SYSTEM TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY DRG REACTDX/MEDICOMP, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other