BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO XT PATCH

    MDR report key: 11658784 · Received April 13, 2021

    Report

    Report Number
    3007208829-2021-00032
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 27, 2021
    Report Date
    March 27, 2021
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSH
    UDI-DI
    00869770000203
    PMA / PMN Number
    K121319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SKIN IRRITATION IS A KNOWN INHERENT RISK OF THE DEVICE. CLINICAL REF. MANUAL ((B)(4)) WARNINGS STATE THE FOLLOWING: DO NOT USE THE ZIO XT PATCH ON PATIENTS WITH KNOWN ALLERGIC REACTION TO ADHESIVES OR HYDROGELS OR WITH FAMILY HISTORY OF ADHESIVE SKIN ALLERGIES. PATIENT MAY EXPERIENCE SKIN IRRITATION. IF SKIN IRRITATION SUCH AS SEVERE REDNESS, ITCHING OR ALLERGIC SYMPTOMS DEVELOP, REMOVE THE ZIO XT PATCH FROM THE PATIENT'S CHEST.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH A PROBABLE CONTACT DERMATITIS WHERE TREATMENT WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553103 ZIO XT PATCH ZIO PATCH DSH IRHYTHM TECHNOLOGIES, INC N100A102X 00869770000203

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention