BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAMSUNG GALAXY WATCH 5

    MDR report key: 18326193 · Received December 13, 2023

    Report

    Report Number
    MW5149240
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    December 10, 2023
    Report Date
    December 11, 2023
    Manufacturer
    SAMSUNG MEDISON CO., LTD.
    Product Code
    PYT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A SAMSUNG GALAXY WATCH 5 WHICH HAD FDA APPROVAL TO ADVERTISE ITS MENSTRUAL CYCLE PREDICTION FEATURE BY UTILIZING SKIN TEMPERATURE WHILE SLEEPING. THE WATCH AND APP REPORT CONFLICTING DATA AND THE PREDICTIONS HAVE NEVER BEEN ACCURATE. ON NOVEMBER 29TH, I CONTACTED SAMSUNG HEALTH ABOUT MY ISSUES WITH THE MEDICAL DEVICE AND DIGITAL APPLICATION. I HAVE BEEN IN CONTACT WITH THEM THE PAST TWO WEEKS. THEY HAVE BEEN UNABLE TO TROUBLESHOOT AND RESOLVE ANY OF THE ISSUES. I LEFT A REVIEW ON THE APP STORE AND THEY REQUESTED I DELETE MY DATA TO TROUBLESHOOT AND WERE UNABLE TO REACH A RESOLUTION. NOW I DON'T HAVE ANY DATA AT ALL. TO INFORM ABOUT FERTILITY DECISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844013 SAMSUNG GALAXY WATCH 5 DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION PYT SAMSUNG MEDISON CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female