BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO XT

    MDR report key: 24835341 · Received April 9, 2026

    Report

    Report Number
    MW5186643
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 7, 2026
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC.
    Product Code
    DSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WORE ZIO HEART MONITOR PATCH BY IRHYTHM (SERIAL# (B)(6)). FROM (B)(6) 2026 EVENING, MY SKIN BELOW ELECTRODES STARTED ITCHY. NEXT DAY, BY DAY 2, IT WAS BURNING AND EXTREMELY PAINFUL. DUE TO THE PAIN, I REMOVED THE PATCH, AND FOUND SEVERE BLISTERING BELOW BOTH THE ELECTRODES, EXACT SIZE OF THE CIRCLE, CAUSING THE PAIN. I CLEANED BLISTERS, APPLIED OINTMENT AND BANDAIDS. I DON'T HAVE ADHESIVE ALLERGIES AND ALL THE REST OF THE BATCH AREAS UNDER ADHESIVE WINGS ARE UNAFFECTED. ONLY BELOW ELECTRODES. I HAVE SEVERE ALLERGIC REACTION TO NICKEL BUT NOT ALLERGIC TO BANDAIDS, ADHESIVES, TAPES, HYDRO-GEL PADS, SILICONE AND OTHER MEDICAL TAPES. I RETURNED ZIO PATCH WITHOUT COMPLETING FULL 14 DAYS BUT IT WAS ABLE TO COLLECT ENOUGH DATA FOR MY DOCTOR TO EVALUATE THE CONDITION. BOTH OF THE BLISTERS TOOK LONG TIME TO START TO HEAL AS THEY WERE RED AND OPEN BUT NOW HEALED WITH SCARS ON MY CHEST. I SPOKE TO IRHYTHM REP (REF# (B)(4)) AND REP ASKED IF I HAD ALLERGIC REACTION TO ADHESIVE, IF I HAVE SENSITIVE SKIN, WHICH I ANSWERED NO. BUT I HAVE SEVERE ALLERGIC REACTION TO NICKELS CAUSING BLISTERS. I DID NOT SEE ANY DISCLAIMERS OR WARNING ABOUT NICKELS BEING USED BUT THE REACTION WAS EXACTLY WHAT I GET WHEN MY SKIN TOUCHES NICKELS AND EXPLAINED TO HER SO. SHE ASKED IF I NEEDED TO GET MEDICAL CARE FOR THE BLISTER, I TOLD HER NO, IT'S HEALING BUT SCARING. IF THERE ARE UNDISCLOSED NICKEL MATERIALS IN ANY PART OF THE PATCH, I COULD HAVE AVOIDED THIS PAINFUL EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898874 ZIO XT RECORDER, MAGNETIC TAPE, MEDICAL DSH IRHYTHM TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other