BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLE WATCH ECG

    MDR report key: 13077182 · Received December 22, 2021

    Report

    Report Number
    MW5106249
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    December 20, 2021
    Report Date
    December 21, 2021
    Manufacturer
    APPLE, INC.
    Product Code
    QDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) WATCH CLAIMS IT CAN READ ECG. MISLEADING. LEAD TO BELIEVE WATCH IS A MEDICAL DEVICE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964572 APPLE WATCH ECG ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA APPLE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male