| maude {mds} | R Documentation |
Bone Cement MAUDE Events in 2017
Description
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).
Usage
maude
Format
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.
Source
https://open.fda.gov/data/maude/