Patient of the facility

Under 21 CFR 803 this decides which events a user facility must report. It reaches beyond patients to employees hurt by a device used at the facility.

Patient of the facility means any individual who is being diagnosed or treated and/or receiving medical care at or under the control or authority of the facility. This includes employees of the facility or individuals affiliated with the facility who, in the course of their duties, suffer a device-related death or serious injury that has or may have been caused or contributed to by a device used at the facility.

21 CFR, 803.3