This document describes how to retrieve medical device reports from the U.S. FDA’s Manufacturer and User Facility Device Experience (MAUDE) database in Nested Knowledge. Navigate to the Literature Search module to get started.Edit
Specify Search Fields #
Be sure to specify the field in the following manner: search term[field_name], using one of MAUDE’s pre-specified fields. Valid field names are:
- mdr_report_key
- brand_name
- generic_name
- manufacturer_name
- report_number
- product_code
- product_problem
- event_type
- mdr_text
- start_date
- end_date
The Search Term can be a single word or multiple words, and may be enclosed in double quotes. The search terms is not case sensitive.
Here are some valid searches:
- Embotrap III[brand name] AND Thrombus retriever[GENERIC NAME]
- “Thrombus retriever”[generic_name]
- 2016-01-1[Start Date] 2019-09-01[end_date] and 100[LIMIT]
- MUE AND (MOM OR LWS)[product_code]
For more information, refer to the MAUDE search on the FDA MAUDE home or the FDA’s data dictionary (in JSON format).Edit
Entering a Boolean Query #
Boolean Operators can be used to specify the structure of your search.mWhen entering your search terms of interest, use:
- AND/OR to separate terms,
- double quotation marks to search for an exact term (which also turns off Automatic Term Mapping), and
- parenthesis to dictate groupings and priority order
- Warning: the NOT operator is not supported by MAUDE.
Valid example searches are:Edit
Search Size and Scope #
MAUDE searches are limited to 10,000 records. Medical Device Reports from the 2009 to the present are available.Edit
Search Results #
Your search will return FDA Medical Device Reports and bibliiographic data. Each report can be uniquely identified by its external id, the MDR Report Key. One Medical Device Report can be linked to more than onr patient and more than one deviceEdit
Disclaimer #
The FDA warns,
Do not rely on openFDA to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of FDA-regulated products. We may limit or otherwise restrict your access to the API in line with our Terms or Service.
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.
For the full description and disclaim see the MAUDE API overview.
