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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATURAL CYCLES NORDIC AB NATURAL CYCLES; DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION
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NATURAL CYCLES NORDIC AB NATURAL CYCLES; DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION Back to Search Results
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
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.
 
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Brand Name
NATURAL CYCLES
Type of Device
DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION
Manufacturer (Section D)
NATURAL CYCLES NORDIC AB
MDR Report Key17989997
MDR Text Key326453344
Report NumberMW5147278
Device Sequence Number1
Product Code PYT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Patient Sequence Number1
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