Adverse Event Medical Devices

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

Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through...

Adverse Event Reporting for Medical Devices Under …

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua-or-discussed-covid-19

Blood Purification Devices EUAs Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs Infusion Pump EUAs Personal Protective Equipment …

MDR Adverse Event Codes | FDA

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

What is a Serious Adverse Event? | FDA

https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event

An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the …

Device Adverse Event Overview - Food and Drug …

https://open.fda.gov/apis/device/event/

The openFDA device adverse event API returns data from Manufacturer and User Facility Device Experience (MAUDE), an FDA dataset that contains medical device adverse …

Adverse Event Reporting Data Files | FDA

https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/adverse-event-reporting-data-files

Manufacturer and User Facility Device Experience (MAUDE) data MAUDE data contain reports received by the FDA of adverse events involving medical devices. …

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device …

Tracking Serious Adverse Events for Medical …

https://www.greenlight.guru/blog/serious-adverse-events-medical-devices-gcp

Under the ISO 14155:2020 GCP standard, an Adverse Event (AE) is defined as: An untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including …

Adverse Event Terminology - International Medical …

https://www.imdrf.org/working-groups/adverse-event-terminology

improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events, and …

Database of Adverse Event Notifications (DAEN)

https://www.tga.gov.au/database-adverse-event-notifications-daen-medical-devices

The Database of Adverse Event Notifications - medical devices contains information from reports of adverse events that the TGA has received in relation to medical devices …