BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHPAT ONE

    MDR report key: 19070509 · Received April 8, 2024

    Report

    Report Number
    MW5153647
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 4, 2024
    Manufacturer
    ITAMAR MEDICAL INC.
    Product Code
    MNR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHEN DOING AN AT HOME SLEEP STUDY WITH THE WATCH PAT ONE PRODUCT, I SUFFERED A BURN FROM THE OXYGEN SENSOR TO MY FINGER FROM THE LIGHT INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418282 WATCHPAT ONE VENTILATORY EFFORT RECORDER MNR ITAMAR MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other FLONASE.| LEXAPRO.| LISINOPRIL.| MAGNESIUM B-2.| MULTIVITAMIN.| SUMATRIPTAN (AS NEEDED).