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A Note on MDR (Medical Device Reporting) and FDAzilla PRO
It’s difficult for us to provide accurate MDR due to the lack of form validation and many free-text fields. This means that there are often misspellings and incomplete fields.
For Example, Colorado can be documented as CO or Colorado or colorado.
Another example is Pt or Patient or patient.
Our strategic partner, FOI Services, has this to say about MDRs:
- MDRs are publically available, as you probably know. They (FOI Services) used to keep a database of them, but the FDA began making them available for free. You can access the freebie search engine for the manufacturer and user facility device experience database (MAUDE) here.
- MAUDE replaced the Device Experience Network (DEN) in roughly 1996 (dates of each reporting system differ depending on the type of reporter), but DEN reports themselves are available here.
- All of the dates, file availability, and links, are found here.
- The file to which FDA offers searches of the publicly disclosable data for each report; we haven’t offered access to these in years because of the duplication a FOIA request causes – the response to the FOIA request is either a referral to the online file or copies of forms with no information beyond the data included in the database. That said, we recently came across something that hasn’t gotten much press – read this. It describes a way FDA has allowed one MDR to be submitted for a bunch of incidents.
- When we saw this (earlier this year), we looked around online trying to pull these “secret batch” requests. Unfortunately, these files don’t have any consistent indicator that the report is a batch of MDRs – the ones we’ve seen all look like a regular, one-incident request until you actually read through the MDR, but with no consistent vocabulary finding these among the others is hit or miss. Here‘s a cite to the article we saw earlier this year. We ran it by several device consultants, and they were unaware of this situation although the situation had been published years earlier. Here is another article about it.