MAUDE Extractor

Status: ✅ Working - Uses OpenFDA MAUDE API

Best for

This actor queries the FDA MAUDE (Manufacturer and User Facility Device Experience) adverse event database to return normalized medical device adverse event and injury reports.

Capabilities

• Search by device name or brand
• Search by manufacturer name
• Filter by date range
• Returns normalized MAUDE adverse event reports

Input

Field	Type	Required	Default	Description
queries	string[]	Yes	-	Device names, brands, manufacturers
maxItemsPerQuery	number	No	100	Max reports per query
startDate	string	No	""	Start date (YYYY-MM-DD)
endDate	string	No	""	End date (YYYY-MM-DD)
includeRaw	boolean	No	false	Attach raw response

Example input

{
  "queries": ["defibrillator", "pacemaker"],
  "maxItemsPerQuery": 100,
  "startDate": "2024-01-01",
  "includeRaw": false
}

Output

Field	Type	Description
source	string	Always "fda-maude"
query	string	Original search
recordType	string	Always "adverse_event_report"
title	string	Device + manufacturer
identifier	string	Event number
date	string	Report date
url	string	FDA MAUDE URL
summary	string	Human-readable summary
deviceName	string	Device/product name
manufacturer	string	Manufacturer name
severityCode	string	Severity code
narrative	string	Event description (truncated)
raw	object	(Optional) Raw response

Example output

{
  "source": "fda-maude",
  "query": "defibrillator",
  "recordType": "adverse_event_report",
  "title": "Implantable Defibrillator - Medtronic",
  "identifier": "MDR-2024-12345",
  "date": "2024-01-15",
  "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/",
  "summary": "Implantable Defibrillator (Medtronic) - High severity - Reported: 2024-01-15. Summary: Device malfunction...",
  "deviceName": "Implantable Defibrillator",
  "manufacturer": "Medtronic Inc.",
  "severityCode": "High",
  "narrative": "Device malfunction reported during procedure..."
}

Notes

• MAUDE Database: FDA Manufacturer and User Facility Device Experience
• Coverage: Medical device adverse event reports from manufacturers and facilities
• Date Range: Data available from 1994 to present
• Severity Codes: Death, Serious Injury, Malfunction
• Privacy: PII redacted in MAUDE reports

Additional notes

Run npm run check to verify syntax:

$npm run check

Additional notes

• FDA MAUDE Database: https://www.fda.gov/medical-devices/device-adventure-event-reporting-maude
• OpenFDA MAUDE API: https://open.fda.gov/apis/device/event/

Pricing

This actor uses the Apify Pay-Per-Event model at $0.002 per dataset item.

Example cost: 1,000 items ≈ $2 in actor charges (plus standard Apify platform compute).