About Manufacturer and User Facility Device Experience (MAUDE)
On this page:
- Description of the MAUDE Database
- Limitations of Medical Device Reports (MDRs)
- Descriptions of Fields in the MAUDE database
Description of the MAUDE Database
The Manufacturer and User Facility Device Experience (MAUDE) database contains medical device reports (MDRs) of adverse events. To further promote transparency, the FDA has begun providing additional information in the MAUDE database, such as device and patient problems and patient demographic information. The FDA will continue to seek ways to improve the MAUDE database and the availability of MDR information.
The MAUDE database:
- Contains the last ten years of MDR data.
- Will be updated every month to include reports received through the last day of the previous month.
- May not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19 prior to June 2019. However, these reports, as well as reports older than ten years, can be found on the MDR Data Files webpage.
The MDR Data Files webpage provides downloadable zipped data files that consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The data in zip files is also updated on a monthly basis.
Please note the following when reading MDRs in the MAUDE database:
- Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by "(b)(4)". If a report contains personal or medical files information, that text is replaced by "(b)(6)". The designations "(b)(4)" and "(b)(6)" can be found in some MDRs and refer to the exemptions in the FOIA. For example, "(b)(4)" may be found in place of the product's composition and "(b)(6)" may be found in place of a patient's date of birth. Certain patient demographic details such as age, sex, weight, race, and ethnicity provided in MDRs are not redacted, provided that the disclosure of such information does not infringe upon the confidentiality of personal identifying information.
Due to database limitations, when the FDA receives a follow-up (or supplemental) report, FDA displays the most recent MDR information in MAUDE; this includes adding additional reported information to certain data fields as noted in the table, Description of Fields in the MAUDE Database below. The Agency continues working to improve the availability of MDR information. - Under 21 CFR 803.19, FDA sometimes grants exemptions, variances, or alternative reporting requirements (see FDA's Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices webpage for more information). Exemptions granted and identified with "RWDYYXXXXX" in the MAUDE database indicate reports where the information submitted by the manufacturer was collected from certain real-world data (RWD) sources, such as registries, electronic health records, or medical claims. "YY" refers to the year the exemption was granted, and "XXXXX" represents the unique RWD exemption identifier.
- Under 21 CFR 803.22(b)(2), manufacturers or importers are required to forward adverse event information to the FDA when they receive such information for a device they did not manufacture or import. The FDA uploads these into and includes an additional statement in the narrative stating, "This report reflects information received by FDA in the form of a notification per 803.22(b)(2)."
Limitations of Medical Device Reports (MDRs)
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. The FDA reviews all MDRs received and evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided, in context with all other relevant medical device information. The submission of an MDR itself does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word "death" or a related term. However, the MDR would not, and should not, be classified as a death unless the reporter believes the patient's cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.
In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. 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. Confirming whether a device caused a specific event can be difficult based solely on information provided in a given report. Establishing a causal relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.
DISCLAIMER: Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. A file of those disclaimers will be placed on the web shortly.
Description of Fields in the MAUDE Database
The following table describes the fields in the MAUDE database in display order. If a submitter did not provide information for a given field, that field will not show in the MDR.
| MAUDE Label | Notes |
|---|---|
| Model Number | Model number found on the device label or accompanying packaging. |
| Device Problem | Submitters are asked to enter codes that most accurately describe medical device failures or problems related to the adverse event. Additional details available on the MDR Adverse Event Codes webpages. Code descriptions can be found on the Coding Resources webpages. Any additional information provided in follow-up reports are added to previously cited device problems. |
| Patient Problem | Submitters are asked to enter codes that most accurately describe patient problems related to the adverse event. Additional details available on the MDR Adverse Event Codes webpages. Code descriptions can be found on the Coding Resources webpages. Any additional information cited in follow-up reports are added to previously provided patient problems. |
| Event Date | Date of the actual or best estimate of the first onset of the adverse event. |
| Event Type | Type of reportable event, e.g., death, injury, or malfunction. |
| Manufacturer Narrative | For manufacturer reports. Manufacturers enter any additional information, evaluation, or clarification of data presented in previous sections, in narrative form. This information is redacted in accordance with 21 CFR 803.9. Any additional information provided in follow-up reports is added to previously provided manufacturer narratives. |
| Event Description | Description of reported event in narrative form. This information is redacted in accordance with 21 CFR 803.9. Any additional information provided in follow-up reports is added to previously provided manufacturer narratives. |
| Brand Name | Trade or proprietary name of the suspect medical device as used in product labeling or in the catalogue. |
| Type of Device | Generic or common name of the suspect medical device or a generally descriptive name. |
| Manufacturer (Section D) | Full name and address of the manufacturer of the suspect medical device. |
| Manufacturer (Section G) | Full name and address of the manufacturer site. |
| Manufacturer Contact | Full name and address of the manufacturer reporting contact. |
| MDR Report Key | Unique key for an MDR, assigned by MAUDE. Follow-up reports do not change this key. |
| MDR Text Key | Unique key for the first narrative entered for this report, assigned by MAUDE. |
| Report Number | Report numbers for mandatory reporters (manufacturers, importers, and user facilities) generally consist of three components: a registration or identification number for the submitter, the 4-digit calendar year, and a consecutive number for each report filed during the year by the submitter (e.g., 1234567-2016-00001, 1234567-2016-00002). Note that user facility identification numbers are redacted. Voluntary reports are identified with an alphanumeric number that begins with "MW" and adds a sequential number. Follow-up reports do not change an MDR's report number. |
| Device Sequence Number | For reports with more than one device, this number differentiates between each device, as each device is displayed separately in the MAUDE search results. |
| Product Code | Product Code of the suspected medical device (refer to the Product Classification Database search webpage for more information). |
| UDI-Device Identifier | The Device Identifier (DI) portion of the medical device's full Unique Device Identifier (UDI) (see FDA's UDI webpage for more information). |
| UDI-Public | Full UDI value with non-releasable Product Identifier (PI) values (such as serial numbers) redacted. |
| Combination Product (y/n) | Denotes whether the suspect product is part of a combination product (see FDA's Combination Products webpage for more information). |
| Reporter Country Code | Denotes the country of the initial reporter (e.g., the user, caregiver, etc.). |
| PMA/PMN Number | Approved PMA or cleared 510(k), or premarket notification (PMN) number for the suspect device. |
| Exemption Number | Exemption/Variance Number used to identify MDR reports that are being submitted under the conditions of an exemption or variance granted by FDA under 21 CFR 803.19. |
| Number of Events Reported | Number of events that are described in the report. |
| Summary Report (Y/N) | Denotes whether the report summarizes multiple reports. Typically applies to reports submitted under an exemption or variance granted by FDA under 21 CFR 803.19, or a report received under FDA's Voluntary Malfunction Summary Report Program. |
| Report Source | Denotes whether this report was submitted by a Manufacturer, Distributor (Importer), User Facility, or Voluntary reporter. |
| Source Type | The source through which the manufacturer became aware of the reported adverse event. |
| Reporter Occupation | Denotes the initial reporter's occupation. |
| Remedial Action | Denotes whether a remedial action (e.g., a recall) was initiated. |
| Type of Report | Denotes whether the report is an initial report or a follow-up report. Note this field adds follow-up reports, also called supplement reports, as they are received, so readers can discern how many follow-up reports have been submitted. For example, a report with two follow-up reports will be denoted as "Initial, Follow-up, Follow-up." |
| Report Date | The date the report is submitted to FDA. If a follow-up report has been submitted, this field will display the date the most recent follow-up report was submitted. Note that if an initial reporter (e.g., an importer or user facility) also sent a report to FDA, this field may include that date in addition to the date the MDR reporter submitted to FDA. |
| [X] Device was involved in event | Number of devices included in the report. |
| [X] Patient was involved in event | Number of patients included in the report. |
| Date FDA Received | Date that the initial report was received in eMDR by FDA. This date marks when FDA first became aware of the reported event and does not change when a follow-up report is received. |
| Is this an Adverse Event Report? | Denotes whether the use of a medical device is suspected to have resulted in an adverse outcome in a patient. |
| Is this a Product Problem Report? | Denotes device malfunctions. |
| Device Operator | Denotes the type of person operating or using the suspect medical device. |
| Device Expiration Date | The expiration date found on the device itself or printed on the accompanying packaging. |
| Device Model Number | Model number found on the device label or accompanying packaging (same as above). |
| Device Catalogue Number | Catalogue number found in the manufacturer's catalogue, device labeling, or accompanying packaging. |
| Device Lot Number | Lot number found on the label or packaging material. |
| Other Device ID Number | Subfield retired in 2018. |
| Was Device Available for Evaluation? | Denotes whether the device was available for evaluation by the manufacturer. |
| Date Returned to Manufacturer | If the device was returned to the manufacturer, denotes the date of return. |
| Is the Reporter a Health Professional? | Denotes whether the initial reporter is a health professional. |
| Was the Report Sent to FDA? | Denotes whether a user facility or importer sent a separate report of the same event to FDA. User facilities are required to send reports of device-related deaths to FDA, and importers are required to send reports of device-associated deaths and serious injuries to FDA. |
| Distributor Facility Aware Date | The date that the user facility's medical personnel or the importer became aware that the device has or may have caused or contributed to the reported event. |
| Device Age | The age of the device or a best estimate. |
| Event Location | The location of actual occurrence of the event. |
| Date Report to Manufacturer | Indicates date report was sent to manufacturer from a user facility or importer. User facilities are required to send reports of device-related deaths and serious injuries to manufacturers, and importers are required to send reports of device-associated deaths, serious injuries and malfunctions to manufacturers. |
| Date Manufacturer Received | For an initial report, this field represents the date when the mandatory reporter received information that a reportable event occurred. For follow-up reports, mandatory reporters are asked to provide the date that the follow-up information was received. MAUDE will display the most recently provided date in this field. |
| Was Device Evaluated by Manufacturer? | Denotes whether the manufacturer evaluated the suspect or a related device. |
| Date Device Manufactured | The date of the manufacturing of the suspect medical device. |
| Is the Device Single Use? | Denotes whether the device was labeled for single use or not. |
| Is This a Reprocessed and Reused Single-Use Device? | Denotes whether a single use device was reprocessed or reused on a patient. |
| Type of Device Usage | Denotes whether the use of the suspect medical device was the initial use, reuse, or unknown. |
| Removal/Correction Number | The correction or removal number following the format directed by 21 CFR Part 806. |
| Patient Sequence Number | For reports with more than one patient, this number differentiates between each patient. Patient fields below this one may be repeated multiple times if the report contains multiple patients. |
| Treatment | Lists concomitant medical products and therapy dates. This information is redacted in accordance with 21 CFR 803.9. |
| Patient Outcome(s) | Patient outcome(s) attributed to the reported event. |
| Patient Age | Patient's age at the time of event onset. |
| Patient Sex | Patient's sex at birth. |
| Patient Weight | Patient's weight or a best estimate. |
| Patient Ethnicity | Patient's ethnicity. |
| Patient Race | Patient's race. |