Device Labeling Problem Evaluation Result

Insufficient, inadequate, or incorrect information provided on a device's label or documentation regarding e.g. as the intended use, directions for use, and characteristics of the device. (Food and Drug Administration)

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Device Labeling Evaluation Method

Reviewing all labeling (including instructions for use, manuals, and packaging) for language related to reported device problems.

Device Labeling Deficiency Evaluation Conclusion

Device problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use).

Device Labeler Support Contact

Support contact information for a device labeler.

Device Labeler

An individual that labels a device.

Device Labeled for Single Use

A device that is intended for one use, or on a single patient during a single procedure (Title 21 Chapter 9 Federal…

Device Known Inherent Risk of Procedure Evaluation Conclusion

Device problems known and documented in the labeling (including both short or long term known complications or adverse reactions).