maude: Bone Cement MAUDE Events in 2017
In mdsstat: Statistical Trending for Medical Devices Surveillance

Description Usage Format Source

A dataset containing 535 events reported into the FDA MAUDE database on bone cement in 2017. Data were obtained via the openFDA API (https://open.fda.gov).

maude

A data frame with 535 rows and 15 variables. Full variable descriptions may be found on the FDA Device Reference Guide (https://open.fda.gov). Note that region is a simulated variable not present in MAUDE. Descriptions as follows:

report_number: Identifying number for the adverse event report.
event_type: Outcomes associated with the adverse event.
date_received: Date the report was received by the FDA.
product_problem_flag: Indicates whether or not a report was about the quality, performance or safety of a device.
adverse_event_flag: Whether the report is about an incident where the use of the device is suspected to have resulted in an adverse outcome in a patient.
report_source_code: Source of the adverse event report.
lot_number: The lot number found on the label or packaging material.
model_number: The exact model number found on the device label or accompanying packaging.
manufacturer_d_name: Device manufacturer name.
manufacturer_d_country: Device manufacturer country.
brand_name: The trade or proprietary name of the suspect medical device as used in product labeling or in the catalog.
device_name: This is the proprietary name, or trade name, of the cleared device.
medical_specialty_description: Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices).
device_class: A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)
region: A simulated, randomly assigned geographical region for package example purposes.