Adverse Event Reporting A G U I D E T O

guide to adverse event reporting

If you’ve been negatively affected by a drug or medical device, it is imperative that this side effect, also known as an adverse event,

is reported to the U.S. Food and Drug Administration (FDA).

When adverse events are reported, the FDA can analyze that data along with the reports of thousands of other consumers experiencing the same symptoms.

Adverse event reporting is essential to improving patient safety.

guide to adverse event reporting

See if your health care provider is willing to file an adverse event report(Form FDA 3500) on your behalf.

In the event that having a medical provider fill out the form is not practical, retrieve the form yourself using one of the following methods:

File the report online athttps://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Print out the Consumer Reporting Form FDA 3500Bwhich can either be mailed or faxed to the FDA

Call the FDA at 1-800-FDA-1088to report over the phone

Determine the type of adverse event that is being reportedUNEXPECTED SIDE EFFECT: A new or worsening condition has arisen as the result of taking

a drug or using a medical device.

MANUFACTURER ISSUE: A problem has arisen with a drug or medical device after usingthe same product made by a different manufacturer.

PRODUCT USE ERROR: A drug or device has been used incorrectly and resulted in an issue

PRODUCT PROBLEMS: There is a problem with the quality of the drug or medical device

U S E T H E F O L LO W I N G G U I D E T O N AV I G AT E T H E Q U E S T I O N S W I T H I N T H E F D A A D V E R S E E V E N T R E P O R T I N G S Y S T E M ( FA E R S ) .

How to File An Adverse Event

guide to adverse event reporting

An FDA adverse event report should be filled with as much useful informationas possible so that the FDA can act accordingly.

NOTE THAT THE FDA WILL NOT RESPOND TO ANY QUESTIONS YOU POSE BUT THAT THEY DO READ THE REPORTS .

NEXT ARE SOME OF THE QUESTIONS THAT THE FDA ASKS DURING ALL ADVERSE EVENT REPORTING. THESE QUESTIONS RELATE TO SECTIONS A, B, E, AND F OF THE FORM. SECTIONS C AND D ARE COVERED

IN THE NEXT SECTION.

If at all possible, gathering the information ahead of time can bea time saver and stress reliever when filing the report.

Preliminary Steps to FilingAn Adverse Event

guide to adverse event reporting

Prepare to respond to the following questions:What kind of problem was it? • Are there new or worsening symptoms? • Is the issue the result of misuse of the product? • Is the issue with the quality of the product? • Has the problem occurred after using the same product from a different manufacturer?

What, if any, serious consequences resulted from the useof this product? • Hospitalization • Intervention to prevent permanent damage • Permanent or temporary disability • New health problems • Life-threatening reaction • Birth defects • Death

When did the problem with the product begin? If it’s a defective product when was it purchased?

Is there any laboratory or testing work done for this problem? If so, what were the results?

What do you recall happening? The more specific your account the better.

Do you still have this product? If possible keep the product in case the FDA requests the product to be sent in. Do not send your product if the FDA did not request it

Are you including a picture of the product with your report? This is recommended as it improves FDA analysis.

If your report is being submitted online, be sure that the picture is also digitally accessible so it can be attached to

your report. Likewise, if you are mailing in your report, be sure a physical copy of the picture is submitted with the form.

What are your identifying and vital statistics?Sect ion E will ask for your Age, Initials, Date of Birth, Gender, Weight, Ethnicity, and Race.

All information submitted in this way is kept confidential and anonymous. This information is only used to determine if there are any demographic trends in the way this device affects individuals.

What, if any, prescribed medications or medical devicesare you currently using? If you aren’t using any medications or devices, write “none.”

What, if any, medical conditions do you have? If you have none write “none” in the response box.

What, if any, allergies do you have? If you have none write “none” in the response box.

Are there any special health circumstances about you? Examples of special health circumstances can include pregnancy, smoking, heavy drinking, or any other conditionor habit which affects your health but hasn’t beenexplicitly requested.

Are you taking any over-the-counter medications, vitamins, minerals, supplements, herbal remedies, or homeopathic treatments?

Do you want to report this issue to the manufacturer?

Do you want to remain anonymous to the manufacturer?

guide to adverse event reporting

Navigating Section C and DSection C and D are two exclusive sections that relate to two separate types

of product that are reported using the adverse event reporting system.For this reason, they are explained separately from the information

which must be filled out in every submission.

SECTION C will be filled out if you are filing an adverse event after usinga drug, cosmetic, dietary supplement, or food.

SECTION D will be filled out if you are filing an adverse event reportafter using a medical device.

If you fill out one section you will skip the other.

guide to adverse event reporting

Section C: Drugs, Cosmetics, Supplements, and FoodsBelow is a list of questions that will help you gather the information necessary to fill out

section C of the FDA adverse event report form.

Which type of product is this about?

• A drug • A cosmetic product • A dietary supplement, vitamin, or mineral • A food product

What is the name of the product as it appears on the bottle? This is one of the reasons filing a picture with your report is helpful.

Who makes this product?

What is the name or names of the companies that make or compound the product?

What kind of product is this?

• Over-the-counter medication • Generic version • Compound Pharmaceutical Product (a drug specially made by a compounding pharmacy) • Biosimilar product

What is the product’s expiration date?

What is the lot number? The lot number can often be found near the expiration date on most products.

The lot number is usually designated by the word LOT next to the number.

What is the NDC (National Drug Code)? Like the lot numbers, NDC numbers can be found labeled on the exterior of the packaging

What is the dosage strength? Is it 100mg? 250mg?

When did you stop using this product?

Approximately how long have you used this drug?

Why did you begin taking this product?

Did your problem stop when you stopped using this product?

Did the problem return when you started using it again?

guide to adverse event reporting

Section D: Medical DevicesBelow is a list of questions that will help you gather the information necessary

to fill out section D of the FDA adverse event report form.

What is the name of the medical device?

Who is the manufacturer of the medical device?

What is the model number of the device? This can be found either on the device or on the medical device product label.

What is the lot number of the device? This can be found either on the device or on the medical device product label.

What is the device’s serial number? Serial numbers can be found on the device, its labeling, or its packaging.

What is the device’s Unique Device Identifier (UDI)? The UDI can be found beneath the device’s barcode on the label of the device.

Was someone using the medical device when the problem occurred?

If someone was using the device, who? • You • A doctor or other healthcare professional • Some other individual

If your device was implanted, when was it implanted?

If it was removed, when was it removed?

If the device was removed, did your symptoms improve?By how much? Quantify using a percentage or scale from 1-10 if possible.

2

LOT

CATUSE BY:

Ultra Implantable™

2020-01-01

Ficticious Medical Device2.25 mm x 8 mm

123456

12345678

CompuHyper GlobalMed®

SINGLE USEDO NOT USEIF PACKAGEIS DAMAGED

QTY: 1 EA

UPPERLIMIT OFTEMPURATURE

KEEP DRY

40°C

Manufacturer

CompuHyperGlobalMed120Technology Dr.Somewhere, XX0000

800-555-1234 (USA)555-555-1234 (All Other)www.chgm.com www.mgfco.uk

MedDevFront UKSomewhereXX12 XXX UK

(01)12345678901234(17)140102(11)10002(10)A1234(21)1234

UNIQUE DEVICE IDENTIFIER

BRAND NAME + DEVICE NAME

LOT

NU

MB

ER

NOTE: THE DIAGRAM ABOVE USES A FICTITIOUS DEVICE TO REPRESENTTHE PRIMARY REPORTING INFORMATION. THE INFORMATION MAY APPEAR

DIFFERENTLY DEPENDING ON THE DEVICE TYPE AND MANUFACTURER.

guide to adverse event reporting

More InformationIf there is any confusion about how to file these forms

not answered by this guide, visit https://www.accessdata.fda.gov/scripts/MedWatchLearn/

to access an interactive practice form thatmay answer your questions.