FDA-compliant post-market surveillance with full transparency. Every adverse event tracked, reported, and resolved publicly.
No serious adverse events reported. All recent reports resolved within SLA. Last update: December 17, 2024
Real-time monitoring across all Openwater devices
Last 90 days of adverse event tracking
Device: OpenLIFU Gen 2
Event Date: Dec 10, 2024
Status: Resolved
User reported difficulty connecting device to institutional network during initial setup. No patient impact. Resolved through updated network configuration guide and IT support training.
View Full Report →Device: OpenLIFU Gen 2
Event Date: Nov 15, 2024
Status: Resolved
Patient reported mild headache during ultrasound treatment session. Symptoms resolved within 2 hours without intervention. Protocol adjusted to include gradual intensity ramp-up for first-time patients. No long-term effects observed in 30-day follow-up.
View Full Report →Device: OpenMOTION v3.0
Event Date: Oct 28, 2024
Status: Resolved
Delayed notification of available software security update. No data breach or patient impact. Notification system enhanced with redundant channels (email + in-app + SMS).
View Full Report →Comprehensive reports submitted to FDA
8 reports filed (6 minor, 2 moderate, 0 serious). All resolved within 7-day SLA. Protocol improvements implemented for patient comfort. Zero serious adverse events.
Download Full Report (PDF) →5 reports filed (4 minor, 1 moderate, 0 serious). Software stability improvements deployed. Enhanced user training materials developed.
Download Full Report (PDF) →11 reports filed (9 minor, 2 moderate, 0 serious). Network connectivity documentation improved. Clinical site IT support protocols established.
Download Full Report (PDF) →3 reports filed (3 minor, 0 moderate, 0 serious). Early deployment phase with limited sites. All issues resolved through documentation updates.
Download Full Report (PDF) →Meeting federal requirements for post-market surveillance
All adverse events are reported to the FDA through the MAUDE (Manufacturer and User Facility Device Experience) database within required timelines. Serious events reported within 30 days, malfunctions within 5 business days. Full transparency maintained through this public registry.
Internal review & resolution target
Comprehensive FDA submissions
Immediate notification system
Help us maintain the highest safety standards. All reports are confidential and contribute to continuous improvement.
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