Device Medical Reporting Sentinel System

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FDA's Sentinel Initiative | FDA

https://www.fda.gov/safety/fdas-sentinel-initiative

Sentinel enhances the FDA’s ability to proactively monitor the safety of medical products after they have reached the market and complements the Agency’s existing Adverse Event Reporting System.

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 …

FDA's Sentinel Initiative - Background | FDA

https://www.fda.gov/safety/fdas-sentinel-initiative/fdas-sentinel-initiative-background

In May 2008, the FDA launched the Sentinel Initiative to create a national electronic system, the Sentinel System, for medical product safety surveillance. The …

Sentinel System Overview - Food and Drug …

https://www.fda.gov/media/110795/download

2 Sentinel is: • FDA’s medical product safety surveillance system created in response to a Congressional mandate • Primarily electronic healthcare and

Sentinel | Spacelabs Healthcare

https://spacelabshealthcare.com/products/diagnostic-cardiology/connectivity/sentinel/

Sentinel can be directly integrated with an organization’s electronic medical record (EMR), accessed on the go via mobile devices, and serve as a conduit to send recordings to …

Devices & Radiological Health Studies | Sentinel Initiative

https://www.sentinelinitiative.org/studies/devices-radiological-health

The U.S. FDA’s Center for Devices and Radiological Health (CDRH) assures that patients and health care providers have timely and continued access to safe, effective, and high …

Medical device reporting—a model for patient safety

https://www.myamericannurse.com/medical-device-reporting-model-patient-safety/

2. Remove the device immediately and tag it with a label describing the problem. 3. Report the incident through the appropriate channels per your facility’s policy. If you are a hospital-based nurse, you …

SENTINEL™ Cerebral Protection System - Boston …

https://www.bostonscientific.com/en-US/products/embolic-protection/sentinel-cerebral-protection-system.html

Indications for Use. The SENTINEL™ Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing TAVR (transcatheter aortic valve …