FDA Adverse Event Malfunction Summary report: N

EVIE RING

MDR report key: 23208968 · Received October 3, 2025

Report

Report Number
MW5176890
Event Type
Malfunction
Date Received
October 3, 2025
Date of Event
September 26, 2025
Report Date
September 29, 2025
Manufacturer
MOVANO INC. DBA MOVANO HEALTH
Product Code
DQA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

WHOM IT MAY CONCERN, I AM WRITING TO FORMALLY SUBMIT A CLAIM REGARDING A SERIOUS AND UNRESOLVED DATA SECURITY ISSUE WITH THE EVIE RING AND ITS ASSOCIATED MOBILE APPLICATION. I AM A CURRENT CUSTOMER, AND WITHOUT WARNING, MY ACCOUNT WAS DELETED FROM THE SYSTEM. I DID NOT INITIATE THIS DELETION, YET ALL OF MY PERSONAL HEALTH DATA--INCLUDING SENSITIVE INFORMATION COLLECTED SINCE AUGUST, HAS DISAPPEARED. THE CUSTOMER CARE TEAM CONFIRMED THAT MY ACCOUNT IS NO LONGER RECOGNIZED, AND THEY HAVE BEEN UNABLE TO PROVIDE ANY EXPLANATION FROM THEIR ENGINEERING TEAM AS TO HOW OR WHY THIS OCCURRED, WHETHER THE DATA IS RECOVERABLE, OR WHAT SECURITY MEASURES ARE IN PLACE TO PREVENT FUTURE BREACHES. THEY ARE ALSO APPARENTLY UNABLE TO GET A RESPONSE FROM THEIR ENGINEERS. THIS RAISES GRAVE CONCERNS ABOUT THE INTEGRITY AND SAFETY OF THE EVIE PLATFORM. IF ACCOUNTS CAN SIMPLY VANISH ALONG WITH PERSONAL HEALTH DATA, THAT CONSTITUTES NOT ONLY A BREACH OF TRUST BUT ALSO A POTENTIAL VIOLATION OF STANDARDS FOR SAFEGUARDING SENSITIVE HEALTH INFORMATION. WHAT IS ESPECIALLY CONCERNING IS THAT, DESPITE THIS UNRESOLVED SECURITY ISSUE, THE FDA HAS JUST APPROVED A NEW RING FOR THIS COMPANY--ONE THAT RELIES ON THE SAME SOFTWARE CURRENTLY IN USE. APPROVING ADDITIONAL DEVICES BUILT ON THIS UNSTABLE AND INSECURE FOUNDATION RISKS EXPANDING THE SCOPE OF THESE DATA PROTECTION FAILURES, POTENTIALLY AFFECTING A LARGER GROUP OF CONSUMERS WHO ARE ENTRUSTING THE PLATFORM WITH THEIR HEALTH INFORMATION. I AM URGING THE FDA TO REVIEW THIS MATTER WITH URGENCY AND HOLD THE COMPANY ACCOUNTABLE FOR ENSURING THE SECURITY, RELIABILITY, AND PROPER STEWARDSHIP OF CONSUMER HEALTH DATA BEFORE ALLOWING FURTHER EXPANSION OF THEIR PRODUCT LINE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2623050 EVIE RING OXIMETER DQA MOVANO INC. DBA MOVANO HEALTH

Patients

Seq Age Sex Outcome Treatment
1 37 YR Female DEXCOM G7.| EVIE RING.| NOVOLOG.| OMNIPOD 5.