Manufacturer And User Facility Device Experience Database

$199 / year

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.

Complexity

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.

Date Created

2010

Last Modified

2018-10-28

Version

2018-10-28

Update Frequency

Weekly

Temporal Coverage

1991 to 2018-10-28

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food and Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

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

Name Description Type Constraints
MDR_Report_KeyThe MDR report keystring-
Event_KeyAdverse event keystring-
Report_NumberMDR report numberstring-
Report_Source_CodeMDR report source codestringenum : Array
Is_Manufacturer_Link_FlagManufacturer Link Flag (internal information Flag)boolean-
Number_Devices_In_EventNumber of devices involved in the eventstring-
Number_Patients_In_EventNumber patient implicated in the eventstring-
Received_DateDate of Reception of the Reportdate-
Is_Adverse_Event_FlagAdverse Event Flagboolean-
Is_Product_Problem_FlagProduct Problem Flagboolean-
Date_ReportReport Datedate-
Event_DateDate of Eventdate-
Reprocessed_And_Reused_FlagSingle Use Flag (Reprocessor Flag)string-
Reporter_Occupation_CodeThe Reporter Occupation Codestring-
Health_ProfessionalHealth Professionalstringenum : Array
Initial_Report_To_FDAInitial Report to FDAstringenum : Array
Date_Facility_AwareDate Facility Awarestring-
Report_DateReport Datedate-
Report_To_FDAReport to FDAstringenum : Array required : 1
Date_Report_To_FDADate Report to FDAdate-
Event_LocationEvent location code keystringrequired : 1
Date_Report_To_ManufacturerDate report to the manufacturerdate-
Manufacturer_Contact_T_NameManufacturer contact title namestring-
Manufacturer_Contact_F_NameManufacturer contact first namestring-
Manufacturer_Contact_L_NameManufacturer contact last namestring-
Manufacturer_Contact_Street_1Manufacturer contact address street first linestring-
Manufacturer_Contact_Street_2Manufacturer contact address street second linestring-
Manufacturer_Contact_CityManufacturer contact citystring-
Manufacturer_Contact_StateManufacturer contact state codestring-
Manufacturer_Contact_Zip_CodeManufacturer contact zip codestring-
Manufacturer_Contact_Zip_ExtManufacturer Contact zip code extensionstring-
Manufacturer_Contact_CountryManufacturer contact country codestring-
Manufacturer_Contact_PostalManufacturer contact postal codestring-
Manufacturer_Contact_Area_CodeManufacturer contact phone area codestring-
Manufacturer_Contact_ExchangeManufacturer contact phone exchange codestring-
Manufacturer_Contact_Phone_NoManufacturer contact phone Numberstring-
Manufacturer_Contact_ExtensionManufacturer contact phone number extensionintegerlevel : Nominal
Manufacturer_Contact_PCountryManufacturer contact phone country codestring-
Manufacturer_Contact_PCityManufacturer contact phone city codestring-
Manufacturer_Contact_PLocalManufacturer contact phone local codestring-
Manufacturer_G1_NameManufacturer namestring-
Manufacturer_G1_Street_1Manufacturer address first line streetstring-
Manufacturer_G1_Street_2Manufacturer address second line streetstring-
Manufacturer_G1_CityManufacturer citystring-
Manufacturer_G1_State_CodeManufacturer state codestring-
Manufacturer_G1_Zip_CodeManufacturer Zip codestring-
Manufacturer_G1_Zip_Code_ExtManufacturer Zip code extensionstring-
Manufacturer_G1_Country_CodeManufacturer country codestring-
Manufacturer_G1_Postal_CodeManufacturer postal codestring-
Date_Manufacturer_ReceivedDate of report reception by the manufacturerdate-
Device_Date_Of_ManufactureDevice manufacturing datedate-
Single_Use_FlagDevice single use flagstringenum : Array
Remedial_ActionRemedial Action:string-
Previous_Use_CodeDevice previous use codestringenum : Array
Removal_Correction_NumberRemoval or correction numberstring-
Event_Type= No answer providedstringrequired : 1
Distributor_NameDevice Distributor Namestring-
Distributor_Address_1Device distributor address first linestring-
Distributor_Address_2Device distributor address second linestring-
Distributor_CityDevice distributor citystring-
Distributor_State_CodeDevice distributor state codestring-
Distributor_Zip_CodeDevice distributor Zip codestring-
Distributor_Zip_Code_ExtDevice distributor Zip code extensionstring-
Report_To_ManufacturerAdverse event report to manufacturerstring-
Manufacturer_NameDevice manufacturer namestring-
Manufacturer_Address_1Device manufacturer Address first linestring-
Manufacturer_Address_2Device manufacturer Address second linestring-
Manufacturer_CityDevice manufacturer citystring-
Manufacturer_State_CodeDevice manufacturer state codestring-
Manufacturer_Zip_CodeDevice manufacturer Zip codestring-
Manufacturer_Zip_Code_ExtDevice manufacturer Zip code zxtensionstring-
Manufacturer_Country_CodeDevice manufacturer country codestring-
Manufacturer_Postal_CodeDevice manufacturer postal codestring-
Type_Of_ReportType of Reportstring-
Source_TypeInvalid datastring-
Added_DateDate addeddaterequired : 1
Changed_DateDate changeddaterequired : 1
MDR_Report_KeyEvent_KeyReport_NumberReport_Source_CodeIs_Manufacturer_Link_FlagNumber_Devices_In_EventNumber_Patients_In_EventReceived_DateIs_Adverse_Event_FlagIs_Product_Problem_FlagDate_ReportEvent_DateReprocessed_And_Reused_FlagReporter_Occupation_CodeHealth_ProfessionalInitial_Report_To_FDADate_Facility_AwareReport_DateReport_To_FDADate_Report_To_FDAEvent_LocationDate_Report_To_ManufacturerManufacturer_Contact_T_NameManufacturer_Contact_F_NameManufacturer_Contact_L_NameManufacturer_Contact_Street_1Manufacturer_Contact_Street_2Manufacturer_Contact_CityManufacturer_Contact_StateManufacturer_Contact_Zip_CodeManufacturer_Contact_Zip_ExtManufacturer_Contact_CountryManufacturer_Contact_PostalManufacturer_Contact_Area_CodeManufacturer_Contact_ExchangeManufacturer_Contact_Phone_NoManufacturer_Contact_ExtensionManufacturer_Contact_PCountryManufacturer_Contact_PCityManufacturer_Contact_PLocalManufacturer_G1_NameManufacturer_G1_Street_1Manufacturer_G1_Street_2Manufacturer_G1_CityManufacturer_G1_State_CodeManufacturer_G1_Zip_CodeManufacturer_G1_Zip_Code_ExtManufacturer_G1_Country_CodeManufacturer_G1_Postal_CodeDate_Manufacturer_ReceivedDevice_Date_Of_ManufactureSingle_Use_FlagRemedial_ActionPrevious_Use_CodeRemoval_Correction_NumberEvent_TypeDistributor_NameDistributor_Address_1Distributor_Address_2Distributor_CityDistributor_State_CodeDistributor_Zip_CodeDistributor_Zip_Code_ExtReport_To_ManufacturerManufacturer_NameManufacturer_Address_1Manufacturer_Address_2Manufacturer_CityManufacturer_State_CodeManufacturer_Zip_CodeManufacturer_Zip_Code_ExtManufacturer_Country_CodeManufacturer_Postal_CodeType_Of_ReportSource_TypeAdded_DateChanged_Date
7605065MW5077862Pfalse2018-06-11I306**INI*N*2018-06-152018-08-29
7650372MW5078161Pfalse2018-06-28N109Y*INIIN*2018-06-292018-09-26
7548933MW5077463Pfalse2018-05-29trueI000**INIIND2018-05-292018-07-17
7905840MW5080083Pfalse2018-09-24trueI000Y*INIINM2018-09-252018-10-18
7276096MW5075282Pfalse2018-02-15trueI305N*INIINM2018-02-162018-06-20
7369249MW5076084Pfalse2018-03-23trueI002Y*INIINM2018-03-262018-05-23
7376801MW5076172Pfalse2018-03-27falsefalseIINIIN*2018-03-282018-05-23
7564957MW5077599Pfalse2018-06-01falsefalseIINIIN*2018-06-042018-06-11
7323073MW5075735Pfalse2018-03-07trueI306**INIININ2018-03-082018-03-11
7327140MW5075775Pfalse2018-03-08falsefalseIINIIN*I2018-03-092018-03-19