BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO XT DTP - UKCA

    MDR report key: 23154089 · Received September 26, 2025

    Report

    Report Number
    3007208829-2025-00214
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 26, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT REVEALED THAT THE PATIENT WORE THE ZIO XT DEVICE FOR 5 OF THE 14 DAYS PRESCRIBED. THE PATIENT HAS SENSITIVE SKIN BUT DOES NOT HAVE A HISTORY OF REACTIONS TO MEDICAL ADHESIVE. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED; HOWEVER, THE PATIENT¿S PREEXISTING SENSITIVITY CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THE ZIO XT CLINICAL REFERENCE MANUAL THAT IS DISTRIBUTED IN THE UNITED KINGDOM PROVIDES A WARNING THAT STATES, ¿PRIOR TO MONITOR APPLICATION, EXAMINE THE SKIN AREA OF THE PATIENT FOR CERTAIN SKIN CONDITIONS (SUCH AS DERMATITIS, ECZEMA, RASHES/HIVES), ACUTE/CHRONIC CUTANEOUS INFECTIONS OR IRRITATION. IF SKIN IRRITATION SUCH AS SEVERE REDNESS." THIS EVENT IS BEING REPORTED PER 21CFR803 AS A SERIOUS INJURY. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY RHYTHM THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED. THESE TERMS ARE INCLUDED IN FORM FDA 3500A AND ARE FIXED TERMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SIGNS OF AN ALLERGIC REACTION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT REPORTED SYMPTOMS OF ITCHING, REDNESS, BLISTERS AND HIVES. THE DEVICE WAS REMOVED, AND THE HCP PRESCRIBED FEXOFENADINE & PREDNISOLONE AS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111810 ZIO XT DTP - UKCA RECORDER, MAGNETIC TAPE, MEDICAL DSH IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention