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

2020-08-30

Version

2020-08-30

Update Frequency

Weekly

Temporal Coverage

1991 to 2020-08-30

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_KeyThe MDR report keystring-
Report_NumberMDR report numberstring-
Report_Source_CodeMDR report source codestringenum : Array ( [0] => D [1] => M [2] => P [3] => U )
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 ( [0] => Y [1] => N [2] => I [3] => * [4] => U )
Initial_Report_To_FDAInitial Report to FDAstringenum : Array ( [0] => Y [1] => N [2] => I [3] => * [4] => U )
Date_Facility_AwareDate Facility Awaredate-
Report_DateReport Datedate-
Report_To_FDAReport to FDAstringenum : Array ( [0] => Y [1] => N [2] => I [3] => * )
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 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 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 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 ( [0] => Y [1] => N [2] => I [3] => * )
Remedial_ActionRemedial Action:string-
Previous_Use_CodeDevice previous use codestringenum : Array ( [0] => I [1] => N [2] => R [3] => * [4] => U )
Removal_Correction_NumberRemoval or correction numberstring-
Event_Type= No answer providedstring-
Source_TypeInvalid datastring-
Added_DateDate addeddate-
Changed_DateDate changeddate-

Data Preview

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 DateReporter Country CodePMA PMN Number
57087533001587388-2015-15451MTrue2021-03-12TrueFalse2016-06-09I*IMRSVIVIANEPAYROU5 RUE GUY MOQUETORSAY91400FR91400SOPHYSA5 RUE GUY MOQUET91400.0FR91400.02015-12-23YUINFOREIGN2016-06-092021-03-25
109884631119779-2020-01208MTrue2021-01-13FalseTrue2021-01-142020-11-03N100.0Y**IBDXBRETTWILKO9450 SOUTH STATE STREETSANDYUT84070US84070801.0801.08015.080152961.08015296192.0BECTON, DICKINSON & CO. (SPARKS)7 LOVETON CIRCLESPARKSMD21152.0US21152.02021-01-122020-07-30NIMOTHER,USER FACILITY2020-12-102021-01-15US
111035182016493-2020-87206MTrue2021-01-01FalseTrue2019-09-18N3.0IN*IMR.BHARATKUMARPRAKASH ARABALLI10020 PACIFIC MESA BLVDSAN DIEGOCA921214386.0US921214386858.0858.08586.085861720.08586172000.0CAREFUSION SD10020 PACIFIC MESA BLVDSAN DIEGOCA92121.04386.0US921214386.02019-01-16NUMOTHER2021-01-012021-01-04USK031741
111035199616066-2020-20712MTrue2021-01-01FalseTrue2021-01-262020-12-01N100.0Y**IBDXBRETTWILKO9450 SOUTH STATE STREETSANDYUT84070US84070801.0801.08015.080152961.08015296192.0SISTEMAS MEDICOS ALARIS, S.A. DE C.V.BLVD. INSURGENTES NO. 20351PARQUE INDUSTRIAL EL FLORIDOTIJUANA22244.0MX22244.02021-01-262020-05-08YIMFOREIGN,OTHER,USER FACILITY2021-01-012021-03-11CO
111035202243072-2020-02273MTrue2021-01-01FalseTrue2021-01-182020-12-04N100.0Y**IBDXBRETTWILKO9450 SOUTH STATE STREETSANDYUT84070US84070801.0801.08015.080152961.08015296192.0BECTON DICKINSON1 BECTON DRIVEFRANKLIN LAKESNJ7417.0US7417.02021-01-18YIMFOREIGN,OTHER,USER FACILITY2021-01-012021-03-11BR
111035219616066-2020-20713MTrue2021-01-01FalseTrue2021-01-062020-12-03N100.0Y**IBDXBRETTWILKO9450 SOUTH STATE STREETSANDYUT84070US84070801.0801.08015.080152961.08015296192.0SISTEMAS MEDICOS ALARIS, S.A. DE C.V.BLVD. INSURGENTES NO. 20351PARQUE INDUSTRIAL EL FLORIDOTIJUANA22244.0MX22244.02021-01-06YIMOTHER,USER FACILITY2021-01-012021-02-03USK944320
111035222016493-2020-87210MTrue2021-01-01FalseTrue2019-09-20N3.0IN*IMR.BHARATKUMARPRAKASH ARABALLI10020 PACIFIC MESA BLVDSAN DIEGOCA921214386.0US921214386858.0858.08586.085861720.08586172000.0CAREFUSION SD10020 PACIFIC MESA BLVDSAN DIEGOCA92121.04386.0US921214386.02015-03-18NUMOTHER2021-01-012021-02-16USK133532
111035233003152976-2020-00597MTrue2021-01-01FalseTrue2021-03-222020-12-04N100.0Y**IBDXBRETTWILKO9450 SOUTH STATE STREETSANDYUT84070US84070801.0801.08015.080152961.08015296192.0BECTON DICKINSON, S.A.CAMINO DE VALDEOLIVIAS/NSAN AGUSTIN DE GUADALIX2021-03-22YIMFOREIGN,OTHER,USER FACILITY2021-01-012021-06-07JA
111035249616066-2020-20714MTrue2021-01-01FalseTrue2021-01-052020-12-04N100.0Y**IBDXBRETTWILKO9450 SOUTH STATE STREETSANDYUT84070US84070801.0801.08015.080152961.08015296192.0SISTEMAS MEDICOS ALARIS, S.A. DE C.V.BLVD. INSURGENTES NO. 20351PARQUE INDUSTRIAL EL FLORIDOTIJUANA22244.0MX22244.02021-01-05YIMOTHER,USER FACILITY2021-01-012021-01-19USK061285
111035252243072-2020-02275MTrue2021-01-01FalseTrue2020-12-302020-11-19N100.0Y**IBDXBRETTWILKO9450 SOUTH STATE STREETSANDYUT84070US84070801.0801.08015.080152961.08015296192.0BECTON DICKINSON1 BECTON DRIVEFRANKLIN LAKESNJ7417.0US7417.02020-12-04YIMDISTRIBUTOR,OTHER2021-01-012021-05-26USUNKNOWN