Characteristics of patients experiencing errors. Health care professionals and consumers directly report adverse events involving medical products and product problems, including medical product errors, to this confidential and protected passive surveillance system. All reports undergo triage and are transferred to the appropriate Center for evaluation and entry into the appropriate FDA database. Mandatory reports of adverse events involving drugs and therapeutic biologic products, including events attributable to a medication error, are received from manufacturers and distributors. Voluntary and mandatory reports are entered into the AERS, which assigns an individual safety-report identification number for each report.
All data undergo data-entry quality control to ensure completeness and accuracy.
Voluntary reports are received via MedWatch . Mandatory reports for device-related adverse events are received from medical device manufacturers. This new reporting system, called MedSuN, will eventually replace the mandatory reporting by all user facilities of medical device-related deaths and serious injuries. These events include deviations from current good manufacturing practices, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of a distributed product. The reports must be submitted as soon as possible, but not more than 45 calendar days from the date the manufacturer acquires information on a reportable event.