BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARDIAN MINI PLUS

    MDR report key: 23124748 · Received September 22, 2025

    Report

    Report Number
    MW5176399
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    September 21, 2025
    Report Date
    September 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER STATED "I WEAR A HEART MONITOR AND IT WAS VERY HARD TO REMOVE ADHESIVE STRIP FROM DEVICE. THIS LED TO SEVERE PAIN AND BRUISING ON MY UPPER CHEST. THE DEVICE WAS DISCONTINUED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201586 BODYGUARDIAN MINI PLUS DETECTOR AND ALARM, ARRHYTHMIA DSI BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. 2452716 15768166

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown