Incident Medical Device

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

Voluntary Medical Device Reporting The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems...

Medical Device Safety | FDA

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety The FDA monitors reports of adverse events and other …

Medical Device Incident Investigation Guidebook

https://accenet.org/publications/Downloads/Reference%20Materials/MDII%202018%20guidebook.pdf

The Veterans Health Administration (VHA) Medical Device Incident Investigation Guidebook was produced through the collaboration of the VHA Center for Engineering and …

MDR Adverse Event Codes | FDA

https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes

Incident reporting for medical devices: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

In the context of incident reporting, information on the incident refers to the circumstances required to be reported under section 59 of the Medical Device …

Incident reporting for medical devices: Guidance …

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021/incident-reporting-medical-devices-guidance-2021-en.pdf

Reportable incidents involving a medical device that affected one or more patients, users or other persons, on the same, or different, dates are to be reported to Health Canada as …

Responsibilities for medical device vigilance …

https://www.bsigroup.com/en-US/medical-devices/resources/Whitepapers-and-articles/responsibilities-for-medical-device-vigilance-reporting/

This paper outlines the requirements specific to incident reporting, vigilance, mandatory problem reporting, medical device reports and adverse event reporting, herein termed …

MAUDE - Manufacturer and User Facility Device …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Device user facilities include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Device user facilities must submit reports when …

Incidents defined under the new Medical Device Regulation

https://www.obelis.net/news/incidents-defined-under-the-new-medical-device-regulation/

Incidents defined under the new Medical Device Regulation. on February 24, 2019. A large number of new requirements in regard to the safety of …