BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARDIAN ONE

    MDR report key: 18544170 · Received January 18, 2024

    Report

    Report Number
    MW5150541
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    December 27, 2023
    Report Date
    January 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BURNED SKIN USING BOSTON SCIENTIFIC CONTINUAL EKG (ELECTROCARDIOGRAM) MONITORING DEVICE BODYGUARDIANONE MODEL 231206 SERIAL #: (B)(6). SKIN BURNED FROM THE ADHESIVE USED TO HOLD ELECTRODES ON SKIN DESPITE REMOVING AND CLEANING SKIN AND REAPPLYING IN NEW LOCATIONS EVERY 3 DAYS. STOPPED USE OF DEVICE FOR 7 DAYS TO ALLOW SKIN TO HEAL BEFORE CONTINUING USE. THERE SHOULD HAVE BEEN A WARNING ABOUT THIS. ADDITIONALLY, WHEN I ASKED MY CARDIOLOGISTS RECEPTIONIST TO FILE AN ADVERSE EVENT, SHE CLAIMED TO NOT KNOW HOW TO FIND THE FORM AND DID NOTHING. SKIN IS STILL HEALING AND SCABBED OVER DESPITE REMOVING LAST ELECTRODES 4 DAYS AGO. USE OF CONTINUOUS HEART MONITORING DEVICE REQUIRED APPLICATION OF ELECTRODES FOR 3-DAY PERIODS. AFTER A DAY THE SITE OF APPLICATION BEGAN TO ITCH AND BURN AND WHEN REMOVED AFTER 3 DAYS OF USE, SKIN WAS RED AND BURNED. DISCONTINUED USE OF DEVICE FOR 7 DAYS TO ALLOW SKIN TO HEAL MID-USE. ADDITIONALLY, DEVICE BATTERIES DID NOT FUNCTION CORRECTLY AND MOST OF THE TIME I ONLY HAD ONE FUNCTIONING BATTERY. VERY FLAWED STUDY WITH LIMITED DATA DUE TO INABILITY TO GET A SECOND BATTERY SENT FOR MORE THAN 10 DAYS WHEN BEGINNING STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836764 BODYGUARDIAN ONE DETECTOR AND ALARM, ARRHYTHMIA DSI BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. 231206

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female METFORMIN.