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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
Medical Device Problem Code Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes Abortion (1688); Pregnancy (3193)
Date of Event 07/10/2019
Type of Reportable Event Serious Injury
Event or Problem 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
Common Device Name
DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION
Manufacturer (Section D)
NATURAL CYCLES NORDIC AB
MDR Report Key8822356
Report NumberMW5088332
Device Sequence Number12435297
Product Code PYT
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 07/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device No Information
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/23/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention; Disability;
Patient Age29 YR
Patient Weight57
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