BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARDIAN HEART

    MDR report key: 8888456 · Received August 12, 2019

    Report

    Report Number
    MW5088972
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    August 8, 2019
    Report Date
    August 8, 2019
    Manufacturer
    PREVENTICE SERVICES, LLC
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS PRESCRIBED HEART MONITOR FOR A MONTH 24/7. GIVEN PREVENTICE BODYGUARDIAN HEART MONITOR. NEED TO ATTACH ELECTRODES TO THE SAME SPOT ALL THE TIME. CANNOT DO IT ANY MORE. IT'S INFLAMED, BLEEDING, INFECTED WOUNDS. CANNOT USE MONITOR AT NIGHTS, TOO HEAVY AND BULKY, LOSING CONTACTS CONSTANTLY. WASTED 30 DAYS OF VALUABLE TIME. THIS MONITOR SHOULD NEVER BE ON A MARKET. SKIN INFLAMMATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680202 BODYGUARDIAN HEART DETECTOR AND ALARM, ARRYTHMIA DSI PREVENTICE SERVICES, LLC REF BC1002-A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other