BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO XT

    MDR report key: 21243578 · Received January 27, 2025

    Report

    Report Number
    MW5165294
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    January 18, 2025
    Report Date
    January 21, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC.
    Product Code
    DSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY HEALTHCARE ISSUED ME A ZIO HEART MONITOR BY IRHYTHM TECHNOLOGIES, INC FOR A DURATION OF 7 DAYS. WITHIN THE 4 MINUTES OF APPLICATION, MY CHEST TURNED BRIGHT RED, IT BURNED AND WAS ITCHY, PLUS AND I STARTED TO EXPERIENCE SHORTNESS OF BREATH. SO I REMOVED THE DEVICE AS QUICKLY AS POSSIBLE BUT WHERE THE ADHESIVE WAS, IT LEFT A HUGE RED MARK, CAUSED A BLOOD BLISTER, ALONG WITH TENDERNESS AND DRYNESS, EVEN AFTER 3 DAYS IT'S OBVIOUS WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240615 ZIO XT RECORDER, MAGNETIC TAPE, MEDICAL DSH IRHYTHM TECHNOLOGIES, INC. NFG0013

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other B12 VITAMIN.| MULTI VITAMIN.| VITAMIN C.