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).
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
is a simulated variable not present in MAUDE. Descriptions as follows:
Identifying number for the adverse event report.
Outcomes associated with the adverse event.
Date the report was received by the FDA.
Indicates whether or not a report was about the quality, performance or safety of a device.
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.
Source of the adverse event report.
The lot number found on the label or packaging material.
The exact model number found on the device label or accompanying packaging.
Device manufacturer name.
Device manufacturer country.
The trade or proprietary name of the suspect medical device as used in product labeling or in the catalog.
This is the proprietary name, or trade name, of the cleared device.
Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices).
A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)
A simulated, randomly assigned geographical region for package example purposes.
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