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Exploration of openFDA adverse events database for medical devices

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openFDA-DeviceEvent

Exploration of openFDA adverse events database for medical devices

Plan

In this project, we are looking for device adverse events. We are particularly interested in: - Cause of failure - Date of failure (ie age of device) We want to see which is the most common cause for given device to fail and at which stage of use this occurs. Relevant fields could be (for full reference see https://open.fda.gov/device/event/reference/):

Event

device_date_of_manufacturer date_of_event, date_report, date_received previous_use_code, remedial_action single_use_flag

Source

reprocessed_and_reused_flag

Device

device.generic_name device.expiration_date_of_device, device.device_age_text device.implant_flag, device.date_removed_flag device.manufacturer_d_name, device.manufacturer_d_state, device.manufacturer_d_country

Patient

patient.sequence_number_outcome, patient.sequence_number_treatment

Report Text

mdr_text.text, mdr_text.text_type_code

Reporter Dependent Fields

By user facility / importer

report_date event_location manufacturer_name, manufacturer_country manufacturer_g1_name, manufacturer_g1_state

OpenFDA fields

device_class

Further interesting fields:

Source: reporter_occupation_code Device: device.device_operator

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Exploration of openFDA adverse events database for medical devices

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