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The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
MedWatch was founded in 1993 to collect data regarding adverse events in healthcare. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary ...
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
The California Department of Public Health (CDPH) is the state department responsible for public health in California. It is a subdivision of the California Health and Human Services Agency . It enforces some of the laws in the California Health and Safety Codes , notably the licensing of some types of healthcare facilities.
Salinas-based international food production giant Taylor Farms had announced a recall on four onion products 'due to potential E. coli contamination.'
The Act obligates frontline personnel to report adverse events to a national reporting system. Hospital owners are obligated to act on the reports and the National Board of Health is obligated to communicate the learning nationally. The reporting system is intended purely for learning and frontline personnel cannot experience sanctions for ...