BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO DEVICE

    MDR report key: 11633558 · Received April 7, 2021

    Report

    Report Number
    MW5100627
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 5, 2021
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC.
    Product Code
    DSH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED STATING SHE WAS EXPERIENCING MODERATE IRRITATION DUE TO THE ADHESIVE FROM THE DEVICE. PATIENT'S SKIN WAS VERY RED WHERE THE DEVICE WAS. THE PATIENT WAS ADVISED TO REMOVE THE DEVICE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526263 ZIO DEVICE RECORDER, MAGNETIC TAPE, MEDICAL DSH IRHYTHM TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR