Details Crucial When Reporting Adverse Events Due to Medical Devices
MedSun: Newsletter #64, September 2011
The American Academy of Pediatrics (AAP) Newsmagazine
Rapid identification of adverse events associated with medical devices is essential to prevent injury or death. Unfortunately, many adverse events reported to the Food and Drug Administration (FDA) do not include vital information such as the patient’s age, which may delay identification of problems in the pediatric population and result in under-reporting of serious adverse events in children.
AAP News: The American Academy of Pediatrics Newsmagazine. Details Crucial When Reporting Adverse Events Due to Medical Devices.