BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL CYCLES

    MDR report key: 17989997 · Received October 23, 2023

    Report

    Report Number
    MW5147278
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Report Date
    October 6, 2023
    Manufacturer
    NATURAL CYCLES NORDIC AB
    Product Code
    PYT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THEY ADVERTISE THAT THIS APP IS FDA APPROVED AS A CONTRACEPTION, BUT THE ALGORITHM THEY USE CANNOT ADAPT TO BREASTFEEDING AND POST-PREGNANCY HORMONAL CHANGES, FROM MY EXPERIENCE. FROM MY CORRESPONDENCES WITH THEM, I¿VE FOUND THAT NATURAL CYCLES RELIES HEAVILY ON PRE-PREGNANCY STATS TO CALCULATE POST-PREGNANCY OVULATION, DESPITE THE FACT HORMONAL CHANGES AFTER PREGNANCY CAN CAUSE BIG CYCLE DIFFERENCES. THE ALGORITHM HAS BEEN OFF BY MANY DAYS FOR MY OVULATION (WHEN USING FACTORS SUCH AS CRAMPING, OVULATION TESTS, AND TEMPERATURE RISES) SEVERAL CYCLES POST BREASTFEEDING. THEY TOLD ME THEIR ALGORITHM USES TEMP RISE AND PAST LUTEAL PHASES, BUT MY LUTEAL PHASE IS VERY DIFFERENT POST BREASTFEEDING. THE APP IS RELYING MORE HEAVILY ON PAST LUTEAL PHASES THAN THE OBVIOUS TEMPERATURE RISE. THEIR ALGORITHM IS FLAWED FOR PEOPLE WHO HAVE SUDDEN CHANGES IN HORMONES/CYCLES, BUT PEOPLE ARE TRUSTING THEM AND THEIR MARKETING FOR CONTRACEPTION. I AM ALL FOR FDA APPROVAL OF NATURAL METHODS, BUT I FEEL THEIR MARKETING ABOUT THE RELIABILITY OF THEIR ALGORITHM IS MISLEADING. I WILL FORWARD MY EMAIL CORRESPONDENCE WITH THEM TO YOU. REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567396 NATURAL CYCLES DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION PYT NATURAL CYCLES NORDIC AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown