Others titles
- Medical Devices Adverse Events
- FDA MAUDE Dataset
Keywords
- Maude
- Device Experience
- MAUDE Manufacturer Reports
- MAUDE Device Recalls
- Device Recall Report
Manufacturer And User Facility Device Experience Database
MAUDE data represents Reports of adverse Events involving medical Devices the datasets consist of voluntary Reports since June 1993, User facility Reports since 1991, Distributor Reports since 1993, and Manufacturer Reports since August 1996.
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Description
Manufacturer and User Facility Device Experience Database represents Reports of adverse Events involving medical Devices.
The dataset contains 75 fields including a MDR Report key, the Report Number and the Date of the Event. The incidents are collected in a publicly available FDA database called MAUDE – short for Manufacturer and User Facility Device Experience. As part of the openFDA project, there is now an Application Programming Interface (API) for this dataset, which provides a way for software to interact directly with the data. This API will allow developers and researchers to easily query thousands of reports dating back to the early 1990s.
About this Dataset
Data Info
Date Created | 2010 |
---|---|
Last Modified | 2022-06-06 |
Version | 2022-06-06 |
Update Frequency |
Weekly |
Temporal Coverage |
1991 to 2022-06-06 |
Spatial Coverage |
United States |
Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Maude, Device Experience, MAUDE Manufacturer Reports, MAUDE Device Recalls, Device Recall Report |
Other Titles | Medical Devices Adverse Events, FDA MAUDE Dataset |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
MDR_Report_Key | The MDR report key | string | - |
Report_Number | MDR report number | string | - |
Report_Source_Code | MDR report source code | string | enum : Array ( [0] => D [1] => M [2] => P [3] => U ) |
Is_Manufacturer_Link_Flag | Manufacturer Link Flag (internal information Flag) | boolean | - |
Received_Date | Date of Reception of the Report | date | - |
Is_Adverse_Event_Flag | Adverse Event Flag | boolean | - |
Is_Product_Problem_Flag | Product Problem Flag | boolean | - |
Date_Report | Report Date | date | - |
Event_Date | Date of Event | date | - |
Reprocessed_And_Reused_Flag | Single Use Flag (Reprocessor Flag) | string | - |
Reporter_Occupation_Code | The Reporter Occupation Code | string | - |
Health_Professional | Health Professional | string | enum : Array ( [0] => Y [1] => N [2] => I [3] => * [4] => U ) |
Initial_Report_To_FDA | Initial Report to FDA | string | enum : Array ( [0] => Y [1] => N [2] => I [3] => * [4] => U ) |
Report_Date | Report Date | date | - |
Report_To_FDA | Report to FDA | string | enum : Array ( [0] => Y [1] => N [2] => I [3] => * ) |
Date_Report_To_FDA | Date Report to FDA | date | - |
Event_Location | Event location code key | string | - |
Date_Report_To_Manufacturer | Date report to the manufacturer | date | - |
Manufacturer_Contact_T_Name | Manufacturer contact title name | string | - |
Manufacturer_Contact_F_Name | Manufacturer contact first name | string | - |
Manufacturer_Contact_L_Name | Manufacturer contact last name | string | - |
Manufacturer_Contact_Street_1 | Manufacturer contact address street first line | string | - |
Manufacturer_Contact_Street_2 | Manufacturer contact address street second line | string | - |
Manufacturer_Contact_City | Manufacturer contact city | string | - |
Manufacturer_Contact_State | Manufacturer contact state code | string | - |
Manufacturer_Contact_Zip_Code | Manufacturer contact zip code | string | - |
Manufacturer_Contact_Zip_Ext | Manufacturer Contact zip code extension | string | - |
Manufacturer_Contact_Country | Manufacturer contact country code | string | - |
Manufacturer_Contact_Postal | Manufacturer contact postal code | string | - |
Manufacturer_Contact_Area_Code | Manufacturer contact phone area code | integer | level : Nominal |
Manufacturer_Contact_Exchange | Manufacturer contact phone exchange code | integer | level : Nominal |
Manufacturer_Contact_Phone_No | Manufacturer contact phone Number | integer | level : Nominal |
Manufacturer_Contact_Extension | Manufacturer contact phone number extension | integer | level : Nominal |
Manufacturer_Contact_PCountry | Manufacturer contact phone country code | string | - |
Manufacturer_Contact_PCity | Manufacturer contact phone city code | string | - |
Manufacturer_Contact_PLocal | Manufacturer contact phone local code | string | - |
Manufacturer_G1_Name | Manufacturer name | string | - |
Manufacturer_G1_Street_1 | Manufacturer address first line street | string | - |
Manufacturer_G1_Street_2 | Manufacturer address second line street | string | - |
Manufacturer_G1_City | Manufacturer city | string | - |
Manufacturer_G1_State_Code | Manufacturer state code | string | - |
Manufacturer_G1_Zip_Code | Manufacturer Zip code | string | - |
Manufacturer_G1_Zip_Code_Ext | Manufacturer Zip code extension | string | - |
Manufacturer_G1_Country_Code | Manufacturer country code | string | - |
Manufacturer_G1_Postal_Code | Manufacturer postal code | string | - |
Date_Manufacturer_Received | Date of report reception by the manufacturer | date | - |
Device_Date_Of_Manufacture | Device manufacturing date | date | - |
Single_Use_Flag | Device single use flag | string | enum : Array ( [0] => Y [1] => N [2] => I [3] => * ) |
Remedial_Action | Remedial Action: | string | - |
Previous_Use_Code | Device previous use code | string | enum : Array ( [0] => I [1] => N [2] => R [3] => * [4] => U ) |
Removal_Correction_Number | Removal or correction number | string | - |
Event_Type | = No answer provided | string | - |
Source_Type | Invalid data | string | - |
Added_Date | Date added | date | - |
Changed_Date | Date changed | date | - |
Reporter_Country_Code | Country abbreviation of the Reporter | string | - |
PMA_PMN_Number | Premarket Approval & Premarket notification number. | string | - |
Data Preview
MDR Report Key | Report Number | Report Source Code | Is Manufacturer Link Flag | Received Date | Is Adverse Event Flag | Is Product Problem Flag | Date Report | Event Date | Reprocessed And Reused Flag | Reporter Occupation Code | Health Professional | Initial Report To FDA | Date Facility Aware | Report Date | Report To FDA | Date Report To FDA | Event Location | Date Report To Manufacturer | Manufacturer Contact T Name | Manufacturer Contact F Name | Manufacturer Contact L Name | Manufacturer Contact Street 1 | Manufacturer Contact Street 2 | Manufacturer Contact City | Manufacturer Contact State | Manufacturer Contact Zip Code | Manufacturer Contact Zip Ext | Manufacturer Contact Country | Manufacturer Contact Postal | Manufacturer Contact Area Code | Manufacturer Contact Exchange | Manufacturer Contact Phone No | Manufacturer Contact Extension | Manufacturer Contact PCountry | Manufacturer Contact PCity | Manufacturer Contact PLocal | Manufacturer G1 Name | Manufacturer G1 Street 1 | Manufacturer G1 Street 2 | Manufacturer G1 City | Manufacturer G1 State Code | Manufacturer G1 Zip Code | Manufacturer G1 Zip Code Ext | Manufacturer G1 Country Code | Manufacturer G1 Postal Code | Date Manufacturer Received | Device Date Of Manufacture | Single Use Flag | Remedial Action | Previous Use Code | Removal Correction Number | Event Type | Source Type | Added Date | Changed Date | Reporter Country Code | PMA PMN Number |
13134632 | 2016493-2021-627488 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-16 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-11 | US | K133532 | |||||||||||||
13134633 | 2016493-2021-627487 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-16 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-11 | US | K133532 | |||||||||||||
13134634 | 2016493-2021-627490 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-16 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-11 | US | K133532 | |||||||||||||
13134635 | 2016493-2021-627489 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-16 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-11 | US | K133532 | |||||||||||||
13134636 | 2016493-2021-627494 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-18 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-11 | US | K133532 | |||||||||||||
13134637 | 2016493-2021-627497 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-18 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-16 | US | K133532 | |||||||||||||
13134638 | 2016493-2021-627496 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-18 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-14 | US | K133532 | |||||||||||||
13134639 | 2016493-2021-627501 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-18 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-11 | US | K133532 | |||||||||||||
13134640 | 2016493-2021-627504 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-20 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-11 | US | K133532 | |||||||||||||
13134641 | 2016493-2021-627503 | M | True | 2022-01-01 | False | True | N | 3 | N | MR. | BRETT | WILKO | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 858 | 858 | 8586 | 85861720 | 8586172000 | CAREFUSION SD | 10020 PACIFIC MESA BLVD | SAN DIEGO | CA | 92121 | 4386 | US | 921214386 | 2021-12-29 | 2012-01-18 | N | RC | U | Z-0026-2018 | M | 0 | 2022-01-01 | 2022-03-11 | US | K133532 |