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A Comparison of Adverse Event Coding of Ophthalmic Medical Device Reports: MedDRA® and FDA Patient Problem Codes

Time

Wed, Jun 27 11:00AM
W 01

Title

A Comparison of Adverse Event Coding of Ophthalmic Medical Device Reports: MedDRA® and FDA Patient Problem Codes

Abstract Summary

Using an internal safety database, 100 medical device cases were analyzed for one-to-one matches between MedDRA and FDA Patient Problem Codes; codes that were similar in medical concept but not exact matches and codes that did not match or had no similarities in concept.

Poster Presenter

Osas Ayela-Uwangue
MD, MPH,
Pharmacoepidemiologist,
Alcon (Novartis Company)
United States

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