The post-pandemic world has recorded over 3 million MDRs (Adverse Events or serious malfunctions) being reported to the Food and Drug Administration. The long-term trend of 20% annual growth increased by 50% in 2022. When compared to 300,000 in 2010, the recent numbers are staggering. The Increase in the Volume of Complaints and MDR reports
Medical Device related Patient infections reported to the FDA jumped by 93% in 2019 and continued smaller increases in 2020 and 2021. For the past 10 years, there has been a 20% increase in the number of MDRs reported to the FDA, and infections followed that increase on average. In 2022, the trend reversed, and
2019-2022 Patient Problem analysis as reported to FDA We are trying to find major keyword patterns across device problems and patient problems that are also present in the B5 and H10 text of MDR reports The most frequent keywords are tracked using counters This exercise is also done by year to see any consistencies or
FDA Received over 2 Million MDRs in 2021 The Coronavirus pandemic did not stop the growth of MDRs reported to the Food and Drug Administration. The long term trend of 20% annual growth has continued in 2021. Over 2 Million MDRs (Adverse Events or serious malfunctions) were reported to the FDA. This is staggering as
Patient Infections reported to the FDA are showing an increase in both absolute and relative numbers. Specifically, over the past 10 years the number of infections reported has increased an average of 28% annually. If you narrow the range to the past 3 years only, the rate of increase jumps to an average of 55%.
MDR submitted to the FDA are showing an increase in the number of patient strokes (Cerebrovascular Accidents/CVA). The increase is in both absolute and relative numbers. Specifically, over the past 10 years the number of strokes reported has increased an average of 17%. If you narrow the range to the past 3 years only, the
Medical Device Reports (MDRs) are typically required to be submitted to the FDA within 30 days of Complaint Awareness. FDA utilizes a variety of Code Types to classify these MDRs. One of these code types is Patient Code which is being split into Health Effect - Clinical Codes and Health Effect - Impact Codes. One
Can MDRs predict when and if a medical device recall will happen? Based on our analysis, one can sometimes tell if a medical device safety recall is about to happen by the sudden big increase in submitted MDRs. As an example, here are 2 separate recalls reported by Allergan in 2019. Recall 1: Because of
One of the projects we have been working on is to take the MAUDE data from the FDA and clean it up. We linked this data to the device registrations and created our own database of parent companies. We looked at what the top MDR submitters were between 2010 and 2019 and some of the
Smarteeva announced the release of its Winter 2021 Post Market Surveillance Suite. Santa Barbara CA - Smarteeva announced the release if it's Winter 2021 Post Market Surveillance Suite which will have enhancements to its Smart Complaint System, FDA MDR Reporting, EU MIR Reporting, and Recall Management. Some of these enhancements include, MDR QuickFill, EUMIR QuickFill,
