When does a user facility report information about adverse events?
A. A user facility (UF) is required to report when it receives information that reasonably suggests that a medical device has (or may have) caused or contributed to a serious injury or death of a patient of the facility: • the report must be submitted within 10 work days • a serious injury must be reported to the manufacturer. (If the manufacturer is unknown, a serious injury must be reported to FDA.) • a death must be reported to the manufacturer and FDA.
