FDA · guide

How to Search the FDA MAUDE Database by Product Code

Updated September 1, 2026

What MAUDE is

The Manufacturer and User Facility Device Experience (MAUDE) database 'houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers' (MAUDE search page). The mandatory reports come from 21 CFR Part 803: a manufacturer must report when it becomes aware that a marketed device 'may have caused or contributed to a death or serious injury' or has malfunctioned in a way that would likely cause death or serious injury if it recurred, no later than 30 calendar days after becoming aware (21 CFR 803.50). The online database holds the last ten years of MDR data; older reports, and reports filed under exemptions granted before June 2019, live in the downloadable MDR Data Files (About MAUDE).

Update cadence

MAUDE is 'updated every month to include reports received through the last day of the previous month', and the zipped data files are also refreshed monthly (About MAUDE). FDA also notes that inclusion of some reports can be delayed by technical or clerical problems. Polling more than once a month therefore rarely produces new records, although the openFDA mirror described below refreshes weekly.

FDA's own limitations, in FDA's words

Before drawing conclusions from any search, read the disclaimer FDA attaches to the data. 'MDR data is not intended to be used either to evaluate rates of adverse events, evaluate a change in event rates over time, or to compare adverse event occurrence rates across devices.' Further, 'the incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use' (About MAUDE). Under 21 CFR 803.16, submitting a report is not an admission that the device caused the event. Trade secret text is replaced with '(b)(4)' and personal information with '(b)(6)'. When FDA receives a supplemental report it displays the most recent information under the same MDR Report Key, so counts of records are not counts of distinct events.

Step 1: find the three-letter product code

FDA identifies generic device types with three-letter product codes such as LRK. The Product Classification database 'contains device names and their associated product codes', and 'the Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892' (Product Code Classification Database). Each record shows the regulation number, device class and review panel, and the downloadable files are updated every Sunday. Search by device name, or copy the product code printed on a competitor's 510(k) clearance letter. A single device family can span several codes, so list all of them before you search.

Step 2: use the MAUDE search form

The search page offers a simple search and an advanced search (MAUDE search page). Simple search matches any term in an MDR received in a selected year and also accepts a UDI. Advanced search exposes specific fields, including:

• Product Code (the three-letter code from Step 1)
• Brand Name and Manufacturer
• Event Type (death, serious injury, malfunction)
• Product Problem (device problem codes)
• Report date range

Both searches return at most 500 results. If a product code generates more than that in your window, narrow the date range or download the MDR Data Files instead.

Step 3: query openFDA by product code

The openFDA device event endpoint serves MAUDE data from 2009 onward and is updated weekly (openFDA device event). The product code lives in the field device.device_report_product_code. Following the documented query syntax, where search takes field:term pairs, AND joins conditions, .exact counts whole phrases and limit caps results, typical requests look like this:

• https://api.fda.gov/device/event.json?search=device.device_report_product_code:LRK&limit=10
• https://api.fda.gov/device/event.json?search=device.device_report_product_code:LRK+AND+date_received:[20250101+TO+20251231]&limit=100
• https://api.fda.gov/device/event.json?search=device.device_report_product_code:LRK&count=event_type.exact

The date-range and count patterns mirror FDA's own examples for this endpoint, which filter on date_received and count by event_type.exact (openFDA example queries). Remember that a weekly API refresh does not change the underlying monthly MAUDE cycle.

Step 4: cross-check with TPLC

The Total Product Life Cycle (TPLC) database 'integrates data by procode' and combines premarket approvals, 510(k)s, MAUDE device problem counts and recalls into one report per product code (TPLC data sources). Its MAUDE and premarket sources are merged monthly, and FDA warns that device problem counts 'may not match the number of reports or the number of events' because one report can carry several problem codes. TPLC is useful for orientation, not for rates.

Reading a result

Read the narrative before counting anything, and remember the reporter's classification of an event is not FDA's conclusion. RegPing's FDA bot delivers these notices into Discord for teams that want product-code-level MDR and recall alerts without manual searching.

Where to verify

• MAUDE search page
• About the MAUDE database
• Product Code Classification Database
• openFDA device event endpoint
• openFDA query syntax
• TPLC data sources and disclaimers
• 21 CFR 803.50 manufacturer reporting

This guide is general information, not legal advice. Verify against the primary source and consult counsel before acting.