NATIONAL BUREAU OF ECONOMIC RESEARCH
NATIONAL BUREAU OF ECONOMIC RESEARCH

MAUDE - FDA Manufacturer and User Facility Device Experience Data

The FDA produces "Manufacturer and User Facility Device Experience" or MAUDE data. The Manufacturer and User Facility Device Experience data "represents reports of adverse events involving medical devices."

The FDA offers an Manufacturer and User Facility Device Experience (MAUDE) searchable database.

The Manufacturer and User Facility Device Experience consists of the four record types: Master Event, Device, Patient, and Text data files.

The four record formats contain all releasable information from MEDWATCH Form 3500 and 3500A.

The source type and type of report variables from the master event data are available in both a wide shape in the full master event files and also separately as long, skinny files. The same is true for the sequence number treatment and sequence number outcome variables from the patient files. SAS has a maximum dataset name length of 32 characters, so the SAS dataset names have been shortened when necessary or desirable.

The FDA Manufacturer and User Facility Device Experience (MAUDE) data is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use. The Text version of the "Text Data" files are delimited by a pipe , "|" , rather than a comma because the foi_text field can include commas.

Updates and changes.

Master Event Data

Variables
Year to Date
New This Month
Changes
Through Previous Year
Source
Stata
SAS
CSV
Desc
Source
Stata
SAS
CSV
Desc
Source
Stata
SAS
CSV
Desc
Source
Stata
SAS
CSV
Desc
All
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
Source Type
dta
sas7bdat
csv
desc
dta
sas7bdat
csv
desc
dta
sas7bdat
csv
desc
dta
sas7bdat
csv
desc
Type of Report
dta
sas7bdat
csv
desc
dta
sas7bdat
csv
desc
dta
sas7bdat
csv
desc
dta
sas7bdat
csv
desc

Patient Data

Variables
Year to Date
New This Month
Changes
Through Previous Year
Source
Stata
SAS
CSV
Desc
Source
Stata
SAS
CSV
Desc
Source
Stata
SAS
CSV
Desc
Source
Stata
SAS
CSV
Desc
All
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc

Device Data
Year to Date
New This Month
Changes
Problem Codes
Source
Stata
SAS
CSV
Desc
Source
Stata
SAS
CSV
Desc
Source
Stata
SAS
CSV
Desc
Source
Stata
SAS
CSV
Desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc

The Text version of the "Text Data" is delimited by the pipe character, "|" , because the foi_text field can have commas .

Text Data
Year to Date
New This Month
Changes
Source
Stata
SAS
Text
Desc
Source
Stata
SAS
Text
Desc
Source
Stata
SAS
Text
Desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc

The Text version of the "Text Data" is delimited by the pipe character, "|" , because the foi_text field can have commas.

Device Data -- Annual
Year
Source
Stata
SAS
CSV
Desc
2016
txt
dta
sas7bdat
csv
desc
2015
txt
dta
sas7bdat
csv
desc
2014
txt
dta
sas7bdat
csv
desc
2013
txt
dta
sas7bdat
csv
desc
2012
txt
dta
sas7bdat
csv
desc
2011
txt
dta
sas7bdat
csv
desc
2010
txt
dta
sas7bdat
csv
desc
2009
txt
dta
sas7bdat
csv
desc
2008
txt
dta
sas7bdat
csv
desc
2007
txt
dta
sas7bdat
csv
desc
2006
txt
dta
sas7bdat
csv
desc
2005
txt
dta
sas7bdat
csv
desc
2004
txt
dta
sas7bdat
csv
desc
2003
txt
dta
sas7bdat
csv
desc
2002
txt
dta
sas7bdat
csv
desc
2001
txt
dta
sas7bdat
csv
desc
2000
txt
dta
sas7bdat
csv
desc
1999
txt
dta
sas7bdat
csv
desc
1998
txt
dta
sas7bdat
csv
desc
Through 1997
txt
dta
sas7bdat
csv
desc
 
Text Data -- Annual
Year
Source
Stata
SAS
Text
Desc
2016
txt
dta
sas7bdat
csv
desc
2015
txt
dta
sas7bdat
csv
desc
2014
txt
dta
sas7bdat
csv
desc
2013
txt
dta
sas7bdat
csv
desc
2012
txt
dta
sas7bdat
csv
desc
2011
txt
dta
sas7bdat
csv
desc
2010
txt
dta
sas7bdat
csv
desc
2009
txt
dta
sas7bdat
csv
desc
2008
txt
dta
sas7bdat
csv
desc
2007
txt
dta
sas7bdat
csv
desc
2006
txt
dta
sas7bdat
csv
desc
2005
txt
dta
sas7bdat
csv
desc
2004
txt
dta
sas7bdat
csv
desc
2003
txt
dta
sas7bdat
csv
desc
2002
txt
dta
sas7bdat
csv
desc
2001
txt
dta
sas7bdat
csv
desc
2000
txt
dta
sas7bdat
csv
desc
1999
txt
dta
sas7bdat
csv
desc
1998
txt
dta
sas7bdat
csv
desc
1997
txt
dta
sas7bdat
csv
desc
1996
txt
dta
sas7bdat
csv
desc
Through 1995
txt
dta
sas7bdat
csv
desc

To report problems or if you have comments or suggestions , e-mail Jean Roth at jroth@nber.org

Last Update Created by Jean Roth April 2, 2015
 
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