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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATURAL CYCLES NORDIC AB NATURAL CYCLES APP; DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION

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NATURAL CYCLES NORDIC AB NATURAL CYCLES APP; DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Abortion (1688); Pregnancy (3193)
Event Date 07/10/2019
Event Type  Injury  
Event Description
Fda approved contraception app natural cycles is a scam.Used properly for just under 4 months before becoming pregnant.Relied on "pull out method" successfully for years before.Used the app correctly, used the recommended ovulation tests (which never gave a positive reading), even though a book about the method to make sure i was doing everything as well as possible.Resulted in a pregnancy and an abortion.After further research it is shocking that this is considered a legitimate contraceptive method with the backing of the fda.Approval of coitus interruptus would be a better use of resources and probably lead fewer pregnancies.It is terrifying how fast women are switching to this type of tracking method in reliance on sleek advertisement and the fda stamp of approval.Fda safety report id# (b)(4).
 
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Brand Name
NATURAL CYCLES APP
Type of Device
DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION
Manufacturer (Section D)
NATURAL CYCLES NORDIC AB
MDR Report Key8822356
MDR Text Key152231019
Report NumberMW5088332
Device Sequence Number1
Product Code PYT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age29 YR
Patient Weight57
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