--- AI Summary: "\\- Developed the MAUDE-Alerts tool for automated email alerts on FDA\ \ Medical Device Reports (MDRs). \n- Utilized openFDA API for real-time data access\ \ and weekly updates. \n- Enhanced user experience with usability features and\ \ CSV export functionality." Anonymous: false Assignee: - J. David Giese Last Edited Time: '2024-10-08T14:37:00+00:00' case_study_510ks: [] client_logo: [] client_name: Innolitics Tool date: '2018-01-27' featured: false medical_panel: Tooling name: FDA MAUDE Database Alerting App services: [] summary: Online tool for subscribing to new alerts in the official FDA database tags: - Web-App testimonials: [] --- ## The Problem The [MAUDE](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) (Manufacturer and User Facility Device Experience) database houses the FDA's MDR's (Medical Device Reports). This database is the official repository of adverse events in the U.S. It is useful to know when new MDR's are added for your device product code. Without tooling, it would require one to manually search the database periodically. We wanted an automatic way of being notified when relevant MDRs were added. ## The Solution In pursuit of our mission to accelerate progress in medical imaging, we created a [free to use tool](https://maude.innolitics.com/) to send email alerts when new adverse events matching search criteria are reported. For example, you may want to know when a injury or death matching your product code is reported. Additionally, you may want to know when new events are reported against your predicate device to be a step ahead of an FDA warning letter. [MAUDE-Alerts](https://maude.innolitics.com/) is a medical device market research tool that automates post-market analysis by sending alerts to you when new Medical Device Reports are reported. [Click here](https://maude.innolitics.com/) to jump right in and try the MAUDE-Alert tool. #### Sign-up & Log-in The sign-up and log-in process for MAUDE-Alerts is password-less meaning you can start using the tool without having to remember yet another password. #### Data Source MAUDE-Alerts is connected to the [openFDA API](https://open.fda.gov/apis/device/event/). This API hosts all MAUDE Medical Device Reports and the database is updated weekly with new reports. The API contains Medical Device Reports from as far back as 1991, whereas the FDA's MAUDE database search tool is limited to reports from the last 10 years. #### Search The MAUDE-Alerts search is modeled after the search form on the MAUDE database search site. As shown in *Figure 1* the same fields are provided to search for MAUDE reports, including a keyword option that searches all reports for a given word.
Figure 1: Search the MAUDE database
Our search form includes several usability enhancements, including auto-filled product code and product class, and Google-like search results design. Additionally it returns double the results returned by the FDA's MAUDE site (1000 compared to 500). #### CSV Export The CSV export is located on the MAUDE-Alerts search results page and update emails. This allows market researchers to share and save data that is noteworthy or requires further analysis. #### Alerts MAUDE-Alerts checks the MAUDE database weekly for any new reports matching your saved searches, *Figure 2*, and sends you an email report if we find anything. You can see an example of a notification email in *Figure 3*. We also give you the option to pause or delete alerts if necessary.
Figure 2: MAUDE Alerts saved searches
Figure 3: MAUDE Alerts email update
#### Conclusions The MAUDE-Alerts website reduces the burden of pre/post market research by keeping you updated on the newest Medical Device Reports. We are confident the widespread adoption of this tool will make the medical device industry a safer place. This website is kept up by the [Innolitics](https://innolitics.com/) developer team. If you use our tool, and would like to propose additional features to the site, please [contact us](https://innolitics.com/about/contact/) with your suggestions! We are currently accepting new software development projects! Please [contact us](https://innolitics.com/about/contact/) if you need an [expert team](https://innolitics.com/about/) of engineers on your side.