The Journal of the American Dental Association
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J Am Dent Assoc, Vol 137, No 1, 18.
© 2006 American Dental Association

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LETTERS

REPORTING PRODUCT DEFECTS

Regarding Dr. Glick’s October editorial, "An Affirmation of Fallibility,"1 dental manufacturers may, on occasion, be faulted for defective equipment or products that injure our patients. These product defects too often remain uncorrected. Consequently, more patients are harmed until the product defect or product warnings are remediated, since few dentists voluntarily comply with the U.S. Food and Drug Administration’s MedWatch to report product defects or inadequate product warnings.

Confidential adverse incident reports by dentists to the FDA can help reverse the present grossly underreported adverse incidents to the FDA, and ultimately notify the manufacturer sooner to remedy any product defects.

Unfortunately, the marketplace too often replaces absent long-term clinical studies in the manufacturer’s rush to market new products.


   REFERENCES
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  1. Glick M. An affirmation of fallibility. JADA 2005;136:1356, 8.



Edwin J. Zinman, DDS

San Francisco



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