BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARDIAN MINI EL

    MDR report key: 13385912 · Received January 27, 2022

    Report

    Report Number
    MW5107046
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    January 23, 2022
    Report Date
    January 25, 2022
    Manufacturer
    PREVENTICE SERVICES, LLC
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS WEARING A HEART MONITOR. THE STRIP THAT HAD THE LEADS ON IT HAD ACRYLIC ADHESIVE ON IT. IT CAUSED A CHEMICAL BURN ON MY SKIN WHICH LED TO BLISTERING AND SCABBING. THIS COULD HAVE BEEN AVOIDED OR MITIGATED IF THE COMPANY HAD WARNED THE CONSUMER ABOUT IT, BUT THEY DID NOT, NOR DID THEY GIVE ANY INSTRUCTIONS ON HOW TO TREAT THE POSSIBLE ADVERSE REACTION. MY DOCTOR'S OFFICE HAS CONFIRMED THAT THIS DEVICE HAS PREVIOUSLY CAUSED THIS REACTION IN OTHER PATIENTS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843680 BODYGUARDIAN MINI EL DETECTOR AND ALARM, ARRHYTHMIA DSI PREVENTICE SERVICES, LLC B43396

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Other ADVAIR| ALLEGRA| BISOPROLOL| FAMOTIDINE| GUANFACINE| MELOXICAM | MONTELUKAST| WELLBUTRIN | ZYRTEC