Reporting Tip
MedSun: Newsletter #21, February 2008

"Is This Reportable?"

Sometimes the FDA receives the following question concerning medical device adverse event reporting, "Is this reportable?" Strictly speaking, what is "reportable" under the SMDA (Safe Medical Device Act) is well defined - adverse events involving medical devices that have, or may have, contributed to a death or serious injury.

But we also want to encourage you to report "voluntary" adverse events that do not meet the requirements for mandatory reporting.

These are the types of events where a possibly harmful situation is narrowly avoided or has potential for an adverse outcome. Even if a product isn't used because a defect or malfunction is noted on initial inspection, or prior to use, but could be a safety hazard, we'd like to hear about it. Additionally, you should not hesitate to report an event that you believe to be common, since your report may be the one that provides the additional information needed for FDA or device manufacturers to "connect the dots," resulting in action being taken to address the reported problem.

For specific questions about whether or not an event is reportable, CDRH's Reporting Systems Monitoring Branch can be contacted. Voluntary reports can be submitted directly to the FDA's MedWatch Adverse Event Reporting program online, by phone (1-800-FDA-1088), or by returning the postage-paid FDA form 3500 (which may be downloaded from by mail to: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or by fax to: 1-800-FDA-0178.

Additional Information:

Information about user facility medical device reporting requirements, go to

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