Microproduct data guideintermediate

openFDA Device Adverse Events

FDA medical-device adverse-event reports for exploring reported device problems and building bounded safety-research tools.

Start the guide Open official source

At a glance

Difficulty
Intermediate — some data preparation helps
Size
Small · ≤0.1 GB
Formats
JSON, ZIP
Access
API or Download
API key
Not required
Provider
U.S. Food and Drug Administration
Updates
Quarterly
Data terms
Creative Commons CC0 1.0 Universal, with noted third-party exceptions

From source to product signal

Test a product idea in four steps

The openFDA device-event API searches MAUDE reports and can return server-side counts. Start with one device generic name and a bounded receive-date window. Voluntary reports cannot establish causality, incidence, or comparative device safety.

1

Check the setup

  • Python 3.10 or newer
  • A notebook environment such as Jupyter or Google Colab
  • An internet connection
2

Access the data

  1. 1.Read the device-event field documentation and choose one generic device name.
  2. 2.Query a bounded receive-date period and count reported product problems.
  3. 3.Preserve the exact query and retrieval timestamp.
Open official source
3

Run the Python example

Install the packages, then run the notebook cell.

python -m pip install pandas requests

import pandas as pd
import requests

response = requests.get(
    "https://api.fda.gov/device/event.json",
    params={
        "search": 'device.generic_name:"INFUSION PUMP" AND date_received:[20250101 TO 20251231]',
        "count": "product_problems.exact",
    },
    timeout=30,
)
response.raise_for_status()
problems = pd.DataFrame(response.json()["results"])
problems["retrieved_at_utc"] = pd.Timestamp.now(tz="UTC")
print(problems.head(20))
4

Test a useful signal

Summarize reported infusion-pump problems

Identify the most frequently reported product-problem terms for one device type in a bounded year.

  1. 01Confirm the API returned product-problem counts for the generic-name query.
  2. 02Rank the bounded counts and note terms that may reflect duplicate or incomplete reports.
  3. 03State that MAUDE reports do not establish causality, incidence, or comparative device safety.

Dataset details

U.S. Food and Drug Administration is a government source. Last verified 2026-08-18. Temporal coverage: 1991-present device event reports.

Theme

Health, Food & Safety

Domains

Medical DevicesPublic HealthRegulation

Data types

Event DataAggregated Data

Tasks

Safety Signal AnalysisTrend Analysis

Geography

Global

Formats

JSONZIP

Provider

U.S. Food and Drug Administration

Data terms

Creative Commons CC0 1.0 Universal, with noted third-party exceptions