Searching MAUDE

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.

Specify Search Fields #

Be sure to specify the field in the following manner: field_name:search_term, using one of MAUDE’s pre-specified fields. Valid field are described below

• device.mdr_report_key – A unique identifier for a medical device report.
• device.brand_name – The trade or proprietary name of the device.
• device.generic_name – The generic or common name of the medical device (e.g. heart pacemaker).
• device.udi_di – A unique number/alphanumeric code specific to a device version or model.
• manufacturer_d_name – The company that manufacturers the device.
• report_number – Identifying number for the adverse event report. This field can be empty.
• device.device_report_product_code – The three-letter FDA product classification code. See CFR Parts 862-892.
• product_problems – The problems reported to the FDA if there was a concern with device quality, authenticity, performance or safety.
• event_type – Outcomes associated with the event. This can be Death, Injury, Malfunction, Other, or No answer provided.
• mdr_text.text – Narrative text.description of the adverse event.
• date_received – Date the report about this patient was received by the FDA.

For information on each of these fields, review the MAUDE documentation or the technical data dictionary. For a complete list of possible fields, see the OpenFDA Searchable Fields.

Here are some example searches:

• device.brand_name:"embotrap III" AND device.generic_name:"thrombus retriever“
• device.generic_name:"Thrombus retriever" or udi_di:1088670408132
• receive_date:[20160101 TO 20201231]
• device.device_report_product_code:(MUE AND (MOM OR LWS))
• device.udi_di:1088670408132
• device.generic_name:("glucose monitor" OR CGM) AND device.brand_name:(Libra OR "Dexcom G7")

Search Terms: #

By default, the search device.generic_name:glucose monitor will yield results where the generic name contains ‘glucose’ OR ‘monitor’. Use double quotes to retrieve exact phrase matches, e.g. .device.generic_name:"glucose monitor“. For any given field, search terms can be joined and nested with the boolean operators AND and OR, e.g. device.generic_name:("glucose monitor" OR CGM).

Joining Multiple Fields: #

By default, fields with a space between them are joined with the OR operators. For example, the search device.brand_name:dexcom receive_date:[20220101 TO 20240101] will return results where either field match is true. To retrieve results where both fields match, use the AND operator, e.g. device.brand_name:dexcom AND receive_date:[20240101 TO 20241231].

Nested boolean operators are not support across fields. For advanced details, checkout the FDA MAUDE search documentation.

Simple Search #

When users search without using the MAUDE syntax, Nested Knowledge passes the entire search term to the fields: MDR Text, Device UDI_DI, Device Brand Name, and Product Problemss. We retrieve results where the search terms matches any of these fields.

Search Size and Results #

MAUDE searches are limited to 10,000 records. The MAUDE database contains reports from 2009 to the present.

Your search will return FDA Medical Device Reports (MDRs) and associated data. Each report can be uniquely identified by the MDR Report Key. One medical device report can be linked to more than one patient and more than one device.

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 disclaimer see the MAUDE API overview.