What is the difference between MAUDE Report, MDR and MedWatch?

[henry_fong168]

Hi all,

Just want to ask what is the difference between MAUDE Report, MDR and MedWatch? What are some of their examples?

Thanks all!


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[Ronen E]

Hello Henry and welcome to the Cove

Manufacturer and User Facility Device Experience Database - (MAUDE) Adverse Event Reporting Data Files

Adverse Event Reporting Data Files - MAUDE / MDR

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

 

[NicoleinFlorida]

My understanding is
MAUDE: FDA database of adverse event reports. When you file a MDR, the adverse event will be entered into the MAUDE databased.

MDR: Basically, from the manufacturer side. The adverse event meets the requirement of MDR Reportable.

Medwatch: Where you can submit your MDR report on-line.

Based on my limited experience

 

[Ajit Basrur]

Hi all,

Just want to ask what is the difference between MAUDE Report, MDR and MedWatch? What are some of their examples?

Thanks all!

Sent from my iPad using Tapatalk

The MedWatch system collects adverse reports and quality problems, primarily with drugs and medical devices, and also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas). Reporting is done using form 3500, or phone, email, and fax.

Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, namely device-associated deaths, serious injuries and malfunctions.

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

The links provided by Ronen will give additional information