Manufacturer And User Facility Device Experience Database

$447.50 / 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

2019-06-23

Version

2019-06-23

Update Frequency

Weekly

Temporal Coverage

1991 to 2019-06-23

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

NameDescriptionTypeConstraints
MDR_Report_KeyThe MDR report keystring-
Report_NumberMDR report numberstring-
Report_Source_CodeMDR report source codestringenum : Array
Is_Manufacturer_Link_FlagManufacturer Link Flag (internal information Flag)boolean-
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 Awaredate-
Report_DateReport Datedate-
Report_To_FDAReport to FDAstringenum : Array required : 1
Date_Report_To_FDADate Report to FDAdate-
Event_LocationEvent location code keystring-
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 codeintegerlevel : Nominal
Manufacturer_Contact_Zip_ExtManufacturer Contact zip code extensionintegerlevel : Nominal
Manufacturer_Contact_CountryManufacturer contact country codestring-
Manufacturer_Contact_PostalManufacturer contact postal codestring-
Manufacturer_Contact_Area_CodeManufacturer contact phone area codeintegerlevel : Nominal
Manufacturer_Contact_ExchangeManufacturer contact phone exchange codeintegerlevel : Nominal
Manufacturer_Contact_Phone_NoManufacturer contact phone Numberintegerlevel : Nominal
Manufacturer_Contact_ExtensionManufacturer contact phone number extensionintegerlevel : Nominal
Manufacturer_Contact_PCountryManufacturer contact phone country codeintegerlevel : Nominal
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
Source_TypeInvalid datastring-
Added_DateDate addeddaterequired : 1
Changed_DateDate changeddaterequired : 1
MDR Report KeyReport NumberReport Source CodeIs Manufacturer Link FlagReceived 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 TypeSource TypeAdded DateChanged Date
82115702032227-2019-00379MTrue2019-01-03FalseTrue2019-04-152018-12-26N0NN*IGERWINDE GRAAFFCEIBA NORTE IND. PARK #50 ROADJUNCOS777-386.000777-3869818.0818.08185.081854648.08185464805.0MEDTRONIC PUERTO RICO OPERATIONS CO.CEIBA NORTE IND. PARK #50 ROADJUNCOS777-386.000777-38692019-04-102018-02-17NUMCOMPANY REPRESENTATIVE,FOREIG2019-01-032019-04-25
82115713003184527-2018-01382MTrue2019-01-03TrueFalse2018-11-202018-11-20N116YN*IMRS.ASTRIDWEBERNECKARSULMSTRASSE 28GRENCHEN,2540SZ2540THOMMEN MEDICAL AGNECKARSULMSTRASSE 28GRENCHEN,2540SZ25402018-12-212018-02-09YIINHEALTH PROFESSIONAL2019-01-032019-01-30
82115722032227-2019-00378MTrue2019-01-03FalseTrue2019-01-032018-09-26N0IN*IGERWINDE GRAAFFCEIBA NORTE IND. PARK #50 ROADJUNCOS777-386.000777-3869818.0818.08185.081854648.08185464805.0MEDTRONIC PUERTO RICO OPERATIONS CO.CEIBA NORTE IND. PARK #50 ROADJUNCOS777-386.000777-38692018-12-272017-07-18NUMCONSUMER2019-01-032019-01-10
82115733003184527-2018-01383MTrue2019-01-03TrueFalse2018-12-052018-11-17N116YN*IMRS.ASTRIDWEBERNECKARSULMSTRASSE 28GRENCHEN,2540SZ2540THOMMEN MEDICAL AGNECKARSULMSTRASSE 28GRENCHEN,2540SZ25402018-12-212018-06-06YIINHEALTH PROFESSIONAL2019-01-032019-01-30
82115743003184527-2018-01374MTrue2019-01-03TrueFalse2018-11-262018-08-17N116YN*IMRS.ASTRIDWEBERNECKARSULMSTRASSE 28GRENCHEN,2540SZ2540THOMMEN MEDICAL AGNECKARSULMSTRASSE 28GRENCHEN,2540SZ25402018-12-112018-05-22YIINHEALTH PROFESSIONAL2019-01-032019-01-30
82115753003184527-2018-01377MTrue2019-01-03TrueFalse2018-12-052018-11-26N116YN*IMRS.ASTRIDWEBERNECKARSULMSTRASSE 28GRENCHEN,2540SZ2540THOMMEN MEDICAL AGNECKARSULMSTRASSE 28GRENCHEN,2540SZ25402018-12-112017-08-10YIINHEALTH PROFESSIONAL2019-01-032019-01-30
82115763003184527-2018-01375MTrue2019-01-03TrueFalse2018-11-262018-10-03N116YN*IMRS.ASTRIDWEBERNECKARSULMSTRASSE 28GRENCHEN,2540SZ2540THOMMEN MEDICAL AGNECKARSULMSTRASSE 28GRENCHEN,2540SZ25402018-12-112018-05-22YIINHEALTH PROFESSIONAL2019-01-032019-01-30
82115773003184527-2018-01376MTrue2019-01-03TrueFalse2018-11-162018-11-15N116YN*IMRS.ASTRIDWEBERNECKARSULMSTRASSE 28GRENCHEN,2540SZ2540THOMMEN MEDICAL AGNECKARSULMSTRASSE 28GRENCHEN,2540SZ25402018-12-112018-02-09YIINHEALTH PROFESSIONAL2019-01-032019-01-30
82115783003184527-2018-01378MTrue2019-01-03TrueFalse2018-10-302018-10-29N116YN*IMRS.ASTRIDWEBERNECKARSULMSTRASSE 28GRENCHEN,2540SZ2540THOMMEN MEDICAL AGNECKARSULMSTRASSE 28GRENCHEN,2540SZ25402018-12-112017-06-25YIINHEALTH PROFESSIONAL2019-01-032019-01-30
82115792032227-2019-00381MTrue2019-01-03FalseTrue2019-01-032018-11-24N0IN*IGERWINDE GRAAFF18000 DEVONSHIRE ST.NORTHRIDGECA913251219.0US913251219818.0818.08185.081854648.08185464805.0MEDTRONIC MINIMED18000 DEVONSHIRE ST.NORTHRIDGECA913251219.0US9132512192018-12-26YUMCONSUMER2019-01-032019-01-17