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Device adverse events

api.fda.gov/device/event

An adverse event is submitted to the FDA to report any undesirable experience associated with the use of a device, including serious device side effects, product use errors, product quality problems, and therapeutic failures.

About device adverse events

The U.S. Food and Drug Administration (FDA) regulates medical devices in the United States. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines, and medical lasers.

An adverse event report is submitted to the FDA to report serious events or undesirable experiences associated with the use of a medical device.

Adverse event reports

Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and by voluntary reporters (such as health care professionals, patients, and consumers).

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.

See the MAUDE dataset page for more details.

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Reference

See the comprehensive field-by-field reference for more detail about the structure and contents of device adverse event reports.

How to search this endpoint

Make API calls to https://api.fda.gov/device/event.json using search parameters for fields specific to the device adverse events endpoint.

Example API query

One adverse event report

This query searches for all records in a certain date range, and asks for a single one. See the header fields reference for more about date_received. Brackets [ ] are used to specify a range for date, number, or string fields.

See the header fields reference for more about date_received. Brackets [ ] are used to specify a range for date, number, or string fields.

  1. search for all records with date_received between Jan 01, 2013 and Dec 31, 2014. limit to 1 record.

  2. see the header fields reference for more about date_received. Brackets [ ] are used to specify a range for date, number, or string fields.

Example API query

One report involving an x-ray device

This query searches for records matching a certain search term, and asks for a single one.

See the reference for more fields you can use to narrow searches for device adverse event reports.

  1. search for all records with device.generic_name (generic device name) contains x-ray

Example API query

Count of top event types associated with x-ray devices

This query is similar to the prior one, but returns a count of the most frequently reported event types.

The suffix .exact is required by openFDA to count the unique full phrases in the field event_type. Without it, the API will count each word in that field individually—No answer provided would be counted as separate values, No and answer and provided.

See the reference for more fields you can use to count and understand the nature of device adverse event reports.

  1. search for all records with device.generic_name (generic device name) contains x-ray

  2. count the field event_type (outcomes associated with an adverse event report)