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MAUDE – Manufacturer and User Facility Device Experience
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
MAUDE – Manufacturer and User Facility Device Experience
Here is something that might be interesting to browse around in. In the past, about 2015 or so I think, I had found that it didn’t seem to be used much. Not many people seemed to be reporting, despite the numerous mesh lawsuit ads that were on television constantly. It is also difficult to use for isolating information about certain products or manufacturers. But it seems to be much more active now, although most of the entries seem to be passed on from law firms that have reported the problems to the device maker.
If you try to use it, be aware that you have to enter your search terms in the embedded database box, not the FDA search box at the top of the page.
One example of the difficulty in using it is if you search for Progrip reports compared to Bard. If you put Progrip in the Brand Name area, many results will come up. But if you put something like “SoftMesh”, one of Bard’s product names, in the Brand Name area nothing comes up. If you put Bard in the Brand Name box then you’ll get the Bard products, all combined.
I also noticed that C. R. Bard shows up as the Manufacturer of the Bard name products. But SOFRADIM PRODUCTION SAS shows up as the Manufacturer of the Progrip product. But the descriptions in the individual files are all clearly about Medtronic or Covidien Progrip mesh. Be aware of the date range also, it starts out just looking back one year. Also, each search seems to be limited to 500 records. It is archaic database software. It seems that you can only search specific fields but not the description field where the product name might be used.
More of the general chaos that protects the medical device makers. Even now, Medtronic is introducing a polypropylene Progrip product that will only be findable, probably, as part of all of the old polyester products.
Anyway, it’s interesting to look around in. Sometimes you’ll find a case that was reported by a doctor or individual with all of the details.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
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6 Replies
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Actually, here is another. Somebody reported the results of a study to the FDA through the MAUDE system. Apparently the FDA just passes it through to the manufacturer. If the manufacturer says that they don’t see anything to act on, the case is closed.
The FDA is not overseeing or regulating anything. They are actually collecting market results for the manufacturers. It looks like they are doing something but the reality is that they are helping the manufacturers anticipate their legal problems.
It’s actually very strange to see what is happening.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=11617005&pc=FTL
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Last post, just an example. From a 2020 surgery with a da Vinci robot implanting 3D Max. Very familiar story, as far as the mesh implant results. Many of the people talk about “having a life” before. Not simple discomfort reports. Life-altering.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=12303831&pc=FTL
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Another search tip – if you use the word “I” you will get the personal stories. The attorneys all talk in the third person.
“I mesh” brings up a lot, to the 500 limit. To see more you have to limit the search with more search words. Could be very tedious.
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I looked through a few Bard mesh reports and they all look about the same. “Attorney says patient was harned by mesh”. Manufacturer says “No manufacturing lot number is present therefore no conclusion can be drawn”.
The manufacturer is saying that it must be a problem in the manufacturing process. Pretending that it is not a fundamental aspect of the product design. Makes no effort to find out what happened.
The FDA does nothing.
It is pretty depressing reading so be ready if you decide to browse a few. But it’s easy to see where the lawsuits are coming from.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=12479336&pc=FTL
“Manufacturer Narrative
No conclusions can be made. The patient’s attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient. The patient’s attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard mesh (bard flat mesh) (device #1). An additional emdr was submitted to represent the bard/davol marlex mesh (bard flat mesh) (device #2). Should additional information be provided, a supplemental emdr will be submitted. Not returned.Event Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard mesh (bard flat mesh) and bard/davol marlex (bard flat mesh) on (b)(6) 2013. As reported, the patient is making a claim for an adverse patient outcome against both devices. Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device. It is also alleged that the patient experienced emotional distress, sustained personal injury and the device was defective.” -
I have found a new way to get to a different Search menu. Click “Search” on the main MAUDE page. A new, different, page will open up. Click “Adverse Events” from the choices at the top. This will open up a new Search page with a single search box and the option to search All Years or a specific year. Put your search word in the box and many results will come up.
Here is the page that comes up. Not clear why it wouldn’t be on the first page.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
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Here is an example of a report where you can see many useful words in the actual report body that would help to categorize reports. But the search fields are not available on the web site.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=16389972&pc=FTL
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