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Below are detailed descriptions of reportable adverse events, grouped by state or federal agency. Answer the question that appears beneath EACH description. When you're finished, click View Reporting Instructions to move to the next page.

Food & Drug Administration

Death or Serious Injury Related to a Device

If a medical device caused or contributed to a patient death or serious injury, inform the FDA.

The incident is reportable if you become aware of information that reasonably suggests that a device has or may have caused or contributed to the death or serious injury of a patient. This includes instances when the medical device may have merely been a factor in the death or serious injury, including, but not limited to instances of:

  • Failure,
  • Malfunction,
  • Improper or inadequate design,
  • Manufacture,
  • Labeling, or
  • User error.

In this context, "serious injury" is an injury or illness that:

  1. Is life-threatening,
  2. Results in permanent impairment of a body function or permanent damage to a body structure, or
  3. Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Note that the FDA’s definition of medical device is fairly broad. For more information about FDA regulations on adverse events reporting please visit FDA Mandatory Reporting Requirements.

Reference: 21 CFR §§ 803.3, 803.30.

Does your event fit this description?

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