What should I report to MedWatch?

What should I report to MedWatch?

Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.

What is a MedWatch form 3500A?

The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.

What is the difference between Faers and MedWatch?

MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event.

What is MDR in FDA?

Mandatory Medical Device Reporting Requirements The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

How do I submit a MedWatch?

Report via phone/fax within 7 days and follow-up with MedWatch within 15 day reporting period with 15-Day, initial checkbox checked. Submit the MedWatch 3500A within 7 days with 15-Day checkbox unchecked but still indicating initial (essentially, submitting written report “early” as initial report)

How do I submit a MedWatch form?

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

What are the four sections of the MedWatch form that must be completed in order for FDA to properly file it into their databases?

Section A: Patient Information. Section B: Adverse Event or Product Problem. Section C: Product Availability.

How accurate is MedWatch?

More than 25% of the names of reported suspect products were inaccurate, and 31% of suspect product start dates were inaccurate. Higher levels of completion and accuracy were associated with reports filed closer to the date when the adverse event was observed.

What is the purpose of MedWatch?

The FDA developed MedWatch to provide important safety information to consumers and to allow consumers to report serious problems with human medical products.

Who uses MedWatch?

An important FDA program called “MedWatch” allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use.

What is MDR standard?

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

What is MDR report key?

The Master Event file includes two database key fields: MDR REPORT KEY which identifies unique reports and is important for linking most of the MAUDE files together and EVENT KEY which is an internally-generated field used to identify unique events.