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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

 

 

Contact data@nber.org with questions, comments, or suggestions.

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