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.
DPH requires you to report any incident that seriously affected the health or safety of a participant or that caused serious physical injury to the participant.
DPH uses the term “serious incident” to cover several broad categories of reportable events. In addition to the above, it also includes any of the following:
These events are reportable if they occurred on premises covered by your program's license.
Reference: 105 CMR § 158.031(C). (Note that DPH has the regulatory authority to add to this list of serious incidents through guidance.)
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:
This requirement applies to "device user facilities" (as defined in 21 CFR § 803.30), which include, among other facility types, distinct entities that operate for the primary purpose of providing nonsurgical therapeutic care on an outpatient basis. Entities that do not qualify as "device user facilities" may still report voluntarily.
In this context, "serious injury" is an injury or illness that:
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.
