§803.32. If I am a user facility, what information must I submit in my individual adverse event reports? — Inbound Citations

(1) You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known. You must submit the information required by § 803.32. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12(b).

(ii) For each event code provided by the user facility under § 803.32(e)(10) or the importer under § 803.42(e)(10), you must include a statement of whether the type of the event represented by the code is addressed in the device labeling; and