Please feel free to contact xxxx directly. xxxxxx has kindly agreed to look into this issue to figure out what happened and how the problem may be corrected.
Fda 510k database zip#
I have spoken with a member of the Information Analysis Branch and it seems some of the patient outcome information may have been inadvertently excluded from the downloadable zip files. Thank you for your patience while I looked into your inquiry. I then received a follow-up email on 4 August (Friday) I apologize for the delay but hope to have an answer for you next week.ĭivision of Industry and Consumer EducationĬenter for Devices and Radiological Health I am in the process of researching the issue and contacting the medical device reporting staff.
So, at this time I am not clear on why this information is not included in the data sets for 2015 and beyond. Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) e-mail account.Īs far as I am aware, patient outcome information is still collected on so adverse event reporting forms. In particular, it's encouraging to know that the patient outcome information is _still_ captured, and it will probably be added back to the database once they determine what the error is. This is from an email dated 28 July 2017. I've edited out identifying information (and superfluous text). I received the following responses (thus far). I recently contacted the FDA, asking why MAUDE no longer provided patient outcome data.
Instead, the database field that should contain outcome data contains the cryptic entry of "8." (the number 8 with a period). The database no longer reports patient outcomes (it stopped doing so in late 2015). In past years, the MAUDE database had captured patient outcome information (whether the patient died, was hospitalized, suffered some form of disability, etc.). I have previously posted about the FDA's adverse events database for medical devices (known as MAUDE). Maybe I punched in the wrong search term, or maybe I selected an incorrect parameter." I started to think, "Maybe I amgoing crazy. Then I decided that I should take a screenshot of my search results just in case they thought I was crazy.īut this time, when I ran it, I got 62 RESULTS! See pic below. Now, I KNOW there are reports in MAUDE involving the veritas collagen matrix because I've run the search before, so when I got ZERO results, I knew that not only were the "raw" data-files corrupt, but something was also corrupt with the FDA's live search-engine.Īs I was writing my email to the FDA, I started to tell them that their error was NOT ONLY with the "raw" data-set, but their search-engine was corrupted, too! I searched for the word veritas and I got ZERO results. While, I was trying to figure out what was corrupted, I ran a test search using the FDA's MAUDE search-engine ( located here). I won't go into the gory details, but some of the 2018 data seems to have been mistakenly vaporized from the current data-set.
I do this a few times per month, and today I noticed that at least part of the data-set is corrupt. The FDA uses a data-base/search engine known as MAUDE to monitor the safety and malfunctions of FDA approved medical devices.Ī few days ago, I downloaded the FDA's MAUDE "raw" data-set (located here).
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