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- #2 D. SUSPECT MEDICAL DEVICE - - 1. Brand Name 2b. Procode 2. Common Device Name 3. Manufacturer Name, City and State (Continue page3) 3) (Continue on page 6. Relevant Tests/Laboratory Data, Including Dates (Continue page3) 3) (Continue on page 7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, pregnancy, smoking and alcohol use, liver/kidney problems, etc.) Lot # 4. Model # 5. Operator of Device Catalog # Expiration Date (dd-mmm-yyyy) Serial.

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Related content

MedWatch Forms for FDA Safety Reporting | FDA
Feb 26, 2020 — MedWatch for Industry FDA Form 3500A pdf.
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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.

MedWatch, the FDA's medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: Prescription and over-the-counter medicines.

Manufacturers must submit a five-day report on form FDA 3500A within five days under the following two conditions: They become aware that an MDR reportable event, from any source, requires remedial action to prevent an unreasonable risk of substantial harm to the public health.

There are two types of MedWatch forms: MedWatch Form 3500 and MedWatch Form 3500A. MedWatch Form 3500 represents a voluntary reporting form and should be used by consumers, healthcare professionals and patients to report serious adverse events.

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.

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.

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 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