Hello Anon,
The MedSun database https://www.fda.gov/medical-devices/medical-device-safety/medsun-medical-product-safety-network is for reporting done by clinical sites (hospitals) and consumers (for OTC products). The MAUDE database does not equal the MedSun database. So when reviewing post market data, a medical device Manufacturer should look at both. Though keep in mind the "quality" of information contained in MedSun is very low when evaluating post market data. It is ok to get generalised information about failures with a certain device, but there is only the issue or problem reported with no further information which would be contained in the MAUDE database. So, yes helpful to conduct some searches for post market information, but again the quality of information is low.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 28-Feb-2024 17:06
From: Anonymous Member
Subject: Adverse Event Reporting Database
This message was posted by a user wishing to remain anonymous
Hello Everyone,
Upon extensive research, I have gleaned that the MAUDE database serves as a comprehensive resource for anyone to get information on all adverse events that have taken place to far. Conversely, the MedWatch database serves as a platform for the submission of adverse event reports by Manufacturers, importers, and user facilities through the utilization of FDA Form 3500 and 3500A.
The FAERS/AERS database serves as a platform specifically designed for the reporting of adverse events related to drugs and biologics.
What about MEDSUN database??
Please let me know if my understanding is right or wrong. Also, I request to add any other information related to the above topic.
#MedicalDeviceReporting #MedicalDevices #FDA #CDRH