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: M Pregnant: Yes (DD/MM/YYYY) Adverse Event Product Problem (e.g., defects/malfunctions) No Other relevant history including pre-existing medical conditions (e.g. allergies, smoking, alcohol use, hepatic/ renal dysfunction etc.): B. ADR Details ADR term(s): Date reaction(s) started: (DD/MM/YYYY) Date reaction(s) Stopped: (DD/MM/YYYY) Description of adverse events: (including sign and symptoms with specific Death (DD/MM/YYYY) diagnosis, treatment and a.

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Related content

FORM FDA 3500
MEDWATCH. FORM FDA 3500 (2/19). The FDA Safety Information and. Adverse Event Reporting...
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Adverse Event (AE) Report Form
This form is cumulative and captures adverse events of a single participant throughout the...
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FORM FDA 3500A SUPPLEMENT
SECTION A: PATIENT INFORMATION​​ Complete a separate form for each patient. If you are...
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The minimum information required for expedited reporting purposes is: an identifiable patient, the name of a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected and for which, in clinical investigation cases, there is a reasonable ...

The minimum dataset required to consider information as a reportable AE is indeed minimal, namely (1) an identifiable patient, (2) an identifiable reporter, (3) product exposure, and (4) an event.

Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.

Reporting of adverse drug reactions For a report to be valid, only four items of information are required: an identifiable patient, a reaction, a suspected medicinal product and an identifiable reporter.

There are only four requirements for a valid adverse drug reaction report: patient identifier, medicine, reaction, reporter details.

A user facility is required to report a device-related death or a device-related serious injury to the manufacturer and to report a device-related death to FDA. Manufacturers must prepare and submit a complete Form FDA 3500A for each suspect device.

The criteria for a valid case are: an identifiable patient; ● a suspect drug; ● a suspect reaction; ● an identifiable HCP reporter.

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.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232