FDA Manufacturer and User Facility Device Experience

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.

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

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

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