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How to look up Failure Modes on FDA website

J

Jnks_Meddev

#1
Hello Everyone,

I am checking failure modes on FDA websites (TPLC?) for our device and see if there's competitor's mode data/existing data.

Can someone guide me on how to look up for failure modes on FDA website?

Thanks!
 
Last edited by a moderator:
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Marcelo

Inactive Registered Visitor
#2
Medical device reporting does not explicitly requires that failure modes are reported, so you probably won't find specific ones (reporting are usually related to the patient event, not device failures modes (which are usually internal").
 
J

Jnks_Meddev

#3
Thank you for responding! We are a contract manufacturing and so a lot of our products failure modes are not internally tracked as our clients will report it to the FDA and so we use TPLC TPLC - Total Product Life Cycle to find all failure mode's to make sure we have covered all of them in our DFMEA's.
 
T

tomshoup

#5
Hello Everyone,

I am checking failure modes on FDA websites (TPLC?) for our device and see if there's competitor's mode data/existing data.

Can someone guide me on how to look up for failure modes on FDA website?

Thanks!
You can find a wealth of information about failure modes in MAUDE. Theoretically, everything in TPLC should be in MAUDE so I only use MAUDE. By the way, I've asked FDA staff members about using other databases such as MEDSUN and they tell me "stick with MAUDE." The way to use MAUDE is to look for entries based on the product code assigned to your product in the product classification database. In MAUDE, set a wide date range, say 5 years, and see how many reports you get. When I do risk management files for clients I always try to read at least 100 reports (if that many are available) that span 5 to 10 years, as long as the products are reasonably equivalent. You can also find more reports by looking for products with similar attributes though they may be in other product classifications. For example, a pregnancy test requires the user to decide if the color stripe is blue. If your product requires a user to decide what color the indicator on a test strip is, look at reports for other tests that use this method of showing the result. Similarly, if your device is likely to be used without training, look for devices that have that attribute, such as AEDs. This can get pretty messy, especially if there are a lot of product codes for similar products, so design your approach so you can tabulate everything you want to read. Also, the reports are sometimes poorly written and you can get to the end of a report and find out that no injury occurred or the patient wasn't even in the room. But I always learn something about the risks of products I work on by reading lots of these reports.

I've also found it useful to download the FDA databases into Access so I can use its filters rather than the FDA search engine. Don't try that with Excel, it doesn't like more than one or two hundred thousand lines but Access will take a million.
 
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