Enhancements to the CDRH Event Problem Codes
MedSun: Newsletter #37, June 2009

The CDRH Event Problem Codes refer to any of the codes (Device Problem, Device Component *new* or Patient Problem) that are used to describe a reported event. User facilities and importers provide patient and device problem codes in Block F10, Event problem codes.

Recent enhancements have been made to the Event Problem Codes to improve code selection, as well as to promote adverse event report analysis. CDRH will begin accepting the updated codes on July 1, 2009. All inactivated and retired codes will no longer be accepted as valid on April 2, 2010.

You may visit http://www.fda.gov/cdrh/problemcode/ to see more about the code enhancements, as well as tools that have been created to assist you in viewing and selecting the appropriate Event Problem Codes.

Additional Information:

CDRH Event Problem Codes. Online Available:

MedSun Newsletters are available at www.fda.gov/cdrh/medsun