Medical Device Adverse Event

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...

MDR Adverse Event Codes | FDA

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

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 event reports...

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 malfunctions, and …

12 Adverse Event Detection, Processing, …

https://www.ncbi.nlm.nih.gov/books/NBK208615/

Registries that collect information on specific drugs and medical devices need to anticipate the need for adverse event (AE) detection, …

Adverse Event Terminology - International Medical Device …

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 establish …

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 abnormal laboratory findings) …

Adverse Events (AE) with Device Event Reporting | CDISC

https://www.cdisc.org/kb/examples/adverse-events-ae-device-event-reporting-73161712

Adverse Events (AE) with Device Event Reporting | CDISC Apply Adverse Events (AE) with Device Event Reporting Tags Content Title: Adverse Events - Including Device Event Reporting

PMDA Medical Safety Information | Pharmaceuticals and …

https://www.pmda.go.jp/english/safety/info-services/safety-information/0001.html

Among the medical incident reports and adverse drug reaction/malfunction reports that have been collected to date, information on related events that have been repeatedly reported …

Adverse event or incident relating to a medical device …

https://www.lawinsider.com/dictionary/adverse-event-or-incident-relating-to-a-medical-device

Adverse event or incident relating to a medical device means any malfunction of the medical device, performance failures, absence or impaired efficacy of the medical device, inadequacy …