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openFDA Device Adverse Events — MAUDE Reports

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openFDA Device Adverse Events — MAUDE Reports

openFDA Device Adverse Events — MAUDE Reports

Query the FDA's MAUDE database and get flat rows - report number, event type, dates, device brand and generic name, manufacturer and class.

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from $1.00 / 1,000 results

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openFDA Device Adverse Events (MAUDE) — Medical Device Reports

Query the FDA's MAUDE database and get flat rows — report number, event type, dates, device brand and generic name, manufacturer, device class and location.

What you get

reportNumber, eventType, dateReceived, dateOfEvent, deviceBrandName, deviceGenericName, deviceClass, manufacturer, manufacturerCity, manufacturerState.

Sample output

{ "reportNumber": "MDR-2026-1", "eventType": "Injury",
"deviceBrandName": "ACME PUMP", "deviceClass": "2" }

Limitations

  • Reporting is voluntary and lagging. A report is not a proven causation, and the absence of reports is not evidence of safety.
  • Only the first device on each report is mapped; a report naming several devices shows one.
  • Dates arrive as YYYYMMDD strings, as the FDA publishes them, and are not reformatted here.
  • openFDA rate-limits; large sweeps are paced.

Inputs

InputTypeDefaultWhat it does
searchstring—openFDA search syntax, e.g

Stops after 1000 rows or 5 requests, whichever comes first — raise maxItems and maxPages for more. Requests are paced 200 ms apart, and pages are fetched by offset (100 at a time).

The dataset's SUMMARY records truncated and stopReason, so a run that hit a cap says so rather than looking like a source that had nothing more.

Pricing

Pay per result.

Fields

FieldTypeWhat it holds
reportNumbernumberRegulator's identifier for this report. Use it to cite or de-duplicate.
eventTypestringType of event as the regulator categorises it. Event types do not indicate severity.
dateReceivedstringDate the regulator received the report, as opposed to the date the event happened.
dateOfEventstringDate the event happened, as reported. Often approximate, and sometimes after the report was received.
deviceBrandNamestringBrand name of the device, as the manufacturer markets it.
deviceGenericNamestringGeneric or common name of the device.
deviceClassstringRegulatory risk class of the device. A NUMBER in regulatory documents (1, 2, 3), where 3 is highest risk.
manufacturerstringName of the manufacturing organisation as reported. Free text, and not matched to any register, so the same firm appears under several spellings.
manufacturerCitystringCity the device manufacturer reports being in.
manufacturerStatestringState or region the device manufacturer reports being in. Usually a two-letter US state code.