BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO XT PATCH

    MDR report key: 4990677 · Received August 7, 2015

    Report

    Report Number
    3007208829-2015-00005
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 6, 2015
    Manufacturer
    IRHYTHM TECHNOLOGIES INC.
    Product Code
    DSH
    PMA / PMN Number
    K121319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WORE THE DEVICE FOR APPROX. 3 DAYS AND PRESENTED WITH PROBABLE CONTACT DERMATITIS AND A SECONDARY INFECTION TO THEIR HEALTHCARE PROVIDER. PATIENT WAS PRESCRIBED AN ANTIBIOTIC FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521144 ZIO XT PATCH DSH IRHYTHM TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention