BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARNATION AMBULATORY MONITOR

    MDR report key: 24238184 · Received February 2, 2026

    Report

    Report Number
    MW5183163
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    November 28, 2025
    Report Date
    January 28, 2026
    Manufacturer
    BARDY DIAGNOSTICS, INC.
    Product Code
    DSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BRADYCARDIA RX HEART MONITOR CAUSED SEVERE, CONSTANT BURNING IN CHEST WITHIN 2 HOURS. ALSO CAUSED BLEEDING AND SKIN SLOUGHING OFF. HAD THE MONITOR ON FOR A TOTAL OF 36 HOURS BEFORE I HAD TO TAKE OFF. SKIN IS STILL HEALING HEADING INTO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303621 CARNATION AMBULATORY MONITOR RECORDER, MAGNETIC TAPE, MEDICAL DSH BARDY DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention CYMBALTA.| ESCITALOPRAM. | KETOTIFEN EYEDROPS. | LIDOCAINE PATCHES.| PROPRANOLOL. | VIT D SUPPLEMENTS. | VOLTAREN GEL. | ZYRTEC.