BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODY GUARDIAN MINI

    MDR report key: 23109619 · Received September 22, 2025

    Report

    Report Number
    MW5176286
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    September 12, 2025
    Report Date
    September 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE BODY GUARDIAN MINI HEART MONITOR WAS PLACED BY CARDIOLOGIST ON (B)(6) 2025. ELECTRODES WERE CHANGED ON (B)(6) 2025 AFTER THEY FELL OFF WHEN PATIENT WAS SHOWERING. THERE WERE A FEW SMALL BUMPS AROUND THE AREA. ON (B)(6) 2025, THEY FELL OFF ONCE AGAIN, AND WHEN THE AREA WAS CLEANED, THERE WAS EVIDENT REDNESS AS WELL AS AN ACCOMPANYING RASH. IT ALSO FELT AND LOOKED LIKE IT WAS BURNED. WATER PHYSICALLY TOUCHING IT CAUSED THE PATIENT PAIN. USE OF THE PRODUCT WAS CEASED THAT DAY BECAUSE THERE APPEAR TO BE CHEMICAL BURNS ON THE PATIENT'S CHEST WHERE ELECTRODES WERE PLACED ON (B)(6) 2025, THE AREA IS STILL VERY RED WITH AN ACCOMPANYING RASH. ATTEMPTS WERE MADE TO CONTACT THE MANUFACTURER OF THE BODY GUARDIAN MINI TO OBTAIN INFORMATION ON WHAT IS IN THE ELECTRODES, BUT THEIR REPRESENTATIVES WOULD NOT PROVIDE THIS INFORMATION. SERIAL NUMBER OF THE BODY GUARDIAN MINI: (B)(6); USED ELECTRODES WERE THROWN OUT, AND THE MONITOR ITSELF WAS RETURNED TO BOSTON SCIENTIFIC CARDIAC DIAGNOSTICS. PICTURES OF THE BURNS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201670 BODY GUARDIAN MINI DETECTOR AND ALARM, ARRHYTHMIA DSI BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other