FDA 1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness

Section

1932a
FOLD, SEAL, AND RETURN

VETERINARY ADVERSE DRUG REACTION, LACK OF
EFFECTIVENESS OR PRODUCT DEFECT REPORT
(For VOLUNTARY Reporting)

FOOD AND DRUG ADMINISTRATION
7500 Standish Place (HFV-199), Room N403
Rockville, MD 20855

Form Approved: OMB 0910-0645
Expiration Date:

NOTE: This report is authorized by 21 U.S.C 352 (a) and (f). While you are not required to report,
your cooperation is needed to assure comprehensive and timely assessment of product labeling.

Individual Case Safety Report Number (FDA Assigned Number)
Submission Type

Initial

Report Type

Adverse Event

Date of this
Month
Report

Follow-up

Day

Product Problem

Both Adverse Event and Product Problem

Date of Initial Report
(If this report is a
Follow-up)

Year

Month

Day

Year

Sender Information
First Name

Last Name

Street Address

City

State

Postal/Zip Code

Country

Telephone Number

Telephone Number (Other)

Fax Number

e-Mail Address
Sender Category

Veterinarian

Animal Owner

Other Health Care Professional

Physician
Other

Patient
Unknown

Sender Previously Reported to the Manufacturer?

Yes

No

(If Yes, provide the Manufacturer's Case Number below)
Manufacturer's Case Number
No Identity Disclosure (If you do NOT want your identity disclosed to the manufacturer, place an "X" in this box)
Preferred Method of Contact

Telephone

e-Mail

Healthcare Professional Information (If different from Sender Information)
First Name

Last Name

Street Address

City

State

Postal/Zip Code

Country

Telephone Number

FORM FDA 1932a (1/10)

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Telephone Number (Other)

Fax Number

e-Mail Address
Owner Information (If different from Sender Information)
First Name

Last Name

Street Address

City

State

Postal/Zip Code

Country

Telephone Number

Telephone Number (Other)

Fax Number

e-Mail Address
Suspected Product Information
Name of Suspected Product
Dosage Form
(Chewable,
liquid, tablet,
topical, injection,
etc.)

Diagnosis and/or
Reason for Use
of the Product
Date of First
Exposure

Month

Day

Date of Last
Exposure

Year

Month

Day

Year

Duration of Product Use
Product Use Information for Suspected Product
Interval of
Administration
(Frequency)

Dose
Administered
Product Administered By

Route of
Administration

Veterinarian / Veterinary Staff

Owner

Expiration Date

Lot Number

Other

Month

Day

Year

Name of Manufacturer of Suspected Product
Adverse Event Information
High

Veterinarian's Level of Suspicion that Product Caused the Adverse Event

Medium

Low

Unknown

Treatment of Adverse Event
Did Adverse Event Abate After Stopping the Product?

Yes

No

Not Applicable

Did Adverse Event Reappear After Reintroduction of the Product?

Yes

No

Not Applicable

Outcome

FORM FDA 1932a (1/10)

Recovered

Died

Other

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Species
Budgerigar

Cat

Cattle

Cockatiel

Cockatoo

Dog

Ferret

Fish

Goat

Guinea Pig

Horse

Human

Parrot

Pig

Rabbit

Sheep

Other

Breed
Male

Gender

Male Neutered

Female

Age

Female Neutered

Weight
Overall Health Status When Suspected Product Given
Excellent

Good

Fair

Poor

Number of Animals Treated

Critical

Number of Animals Affected

Date of Onset of Adverse Event

Month

Day

Year

Length of Time Between First Exposure to
Suspected Product(s) and Onset of Adverse Event
Length of Time Between Last Administration of
Suspected Product(s) and Onset of Adverse Event
When the Adverse Event Occurred, Treatment with Suspected Product
Had Already Been Completed

Was Discontinued

Was Discontinued and Replaced with Another Product

Was Discontinued and Reintroduced Later

Was Continued at an Altered Dose

Other (Comment Below)

Attached Document Name (Filename if Electronic)
Attached Document Description
Attached Document Name (Filename if Electronic)
Attached Document Description
Attached Document Name (Filename if Electronic)
Attached Document Description
Concurrent Clinical Problem(s)
Were There Concurrent Clinical Problems?

Yes

No

Do Not Know

List Concurrent Clinical
Problem(s)

FORM FDA 1932a (1/10)

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Concurrent Product Information (Excluding Treatment of Current Event)
Please provide name(s), dose(s), interval(s), date(s) of treatment(s), and other relevant information to describe other products that the patient
was taking at the time of the event. Either copy this page as needed to describe the additional products or provide comments in the narrative
box at the end of the form.
Yes

Were Concurrent Products Given?

No

Do Not Know

List Names of Concurrent
Products Administered
Date of First
Exposure

Month

Day

Year

Date of Last
Exposure

Month

Day

Year

Duration of Product Use

Adverse Event/Product Problem
(Long Narrative)

FORM FDA 1932a (1/10)

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INSTRUCTIONS FOR COMPLETING AND SUBMITTING FORM FDA 1932a
GENERAL INSTRUCTIONS
•

Please either type or print all entries in a font
no smaller than 8 point. If filling in the form
by hand, please use black ink.

Sender Information:
Provide the contact
information for the person who is filling out this
form.

•

Please complete all sections that apply.

•

For narrative entries, attach additional pages
as needed.

Reporter Category:
Reporter Category.

•

If attaching additional pages, please do the
following:
o

Identify all attached pages as Page # of
# (e.g., Page 1 of 4);

o

Indicate the appropriate section and
block number next to the narrative
continuation; and

o

Include the phrase continued at the end
of each field that has additional
information continued onto another
page.

Individual Case Safety Report Number: This
number will be assigned by the Food and Drug
Administration (FDA).
Submission Type:
Choose a Submission
Type. If this is the first time you have sent FDA
information about this, choose “Initial” report. If
this is additional information for a previously
submitted report, choose “Follow-up” report.
Report Type: Choose a Report Type. If you
are reporting something that has affected an
animal or a human, including lack of
effectiveness, choose “Adverse Event.” If you
are reporting something associated with a
product (such as crumbled tablets or peculiar
appearance), choose “Product Problem.” If both
situations apply, choose “Both.”
Date of this Report and Date of Initial Report:
Enter dates as mm/dd/yyyy. If exact dates are
unknown, provide the best estimate.

FORM FDA 1932a (1/10)

Choose the appropriate

Manufacturer's Case Number: Fill in the case
number, if applicable or known.
If you
previously reported to the manufacturer, you can
contact the manufacturer for the manufacturer's
case number.
Healthcare Professional Information: Please
provide the name, mailing address, phone
number, and e-mail address of the veterinarian
or other health care professional who can be
contacted to provide information, if such followup is necessary.
If the Health Care Professional is also the
Sender, there is no need to repeat the
information.
Owner's Name: Please provide the owner's
name, mailing address, and phone number. If
the Owner is also the Sender, there is no need
to repeat the information.
The owner's information is held in strict
confidence by FDA and protected to the fullest
extent of the law. The FDA will not disclose
the reporter's identity in response to a
request from the public, pursuant to the
Freedom of Information Act.
Name of Suspected Product:
brand name of the product.

Provide the

Diagnosis and/or Reason for Use: Provide
the reason or indication for which the product
was prescribed or used in the animal.
Dosage Form: Provide the dosage form (e.g.,
chewable tablet, liquid, tablet, topical, injection,
etc.)

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Date(s) of First and Last Exposure: Enter the
date(s) the product was started and stopped. If
actual dates are unknown, enter the
approximate time period the product was used in
the Duration of Product Use box (e.g., 2 weeks
during the summer of 2006). If the product was
used less than 1 day, enter the same date in the
Date of First Exposure and Date of Last
Exposure boxes.
Dose
Administered,
Interval
of
Administration (Frequency), and Route of
Administration: Describe how the product was
administered (e.g., 250 mg), frequency of
administration (e.g., every 12 hours for 5 days),
and how it was administered (e.g., orally,
injection, etc.). Describe how the product was
administered, even if it differs from what was
prescribed.
Product Administered By: Please check the
appropriate box. If given by a member of the
veterinarian's staff, please identify (e.g.,
technician, assistant) in the narrative box at the
end of the form. If given by someone other than
the owner (e.g., pet sitter, trainer), choose
“Owner” but identify in the narrative.
Lot Number and Expiration Date: Please
provide the lot number and expiration date from
the product, if available.
Name of Manufacturer of Suspected Product:
Provide the name of the manufacturer.
Treatment of Adverse Event: If the adverse
event was treated, describe the treatment given.
Did Adverse Event Abate after Stopping the
Product?
Choose “Yes” if the adverse event lessened or
went away when the product was stopped or the
dose was decreased.
Choose “Not Applicable” if the product was not
stopped or decreased.

FORM FDA 1932a (1/10)

Outcome: Choose an Outcome for the adverse
event.
If “Other” is chosen, describe this
outcome in the narrative at the end of the form
(e.g., the dog lived but never recovered fully,
since it was left with a permanent elevation of
liver enzymes).
Species: Choose a box for species (e.g., cat,
dog, ferret, horse, human, other, etc.). If “Other”
is chosen, identify the species in the narrative
box at the end of the form.
Breed: Enter the breed (e.g., Yorkie, Mixed
Breed, Lab mix, Siamese/Persian mix). Note:
This category is not applicable if the patient is
human.
Age: Provide the patient's age at the time of the
adverse event, including a time descriptor (e.g.,
8 years). Provide the best estimate if exact age
is unknown.
Weight: Provide the patient's weight in pounds
(lb). Make a best estimate if exact weight is
unknown.
Overall Health Status: Check the box that best
describes the patient's overall state of health
when drug/product was first given.
Number of Animals Treated: If more than one
animal was treated with the same drug/product
at the same time, please tell us how many were
treated (e.g., two kittens received Drug X).
Number of Animals Affected: If more than
one animal had an adverse event after the
treatment, please tell us how many. If more
than one animal had an adverse event, and the
reaction was not the same, please submit a
separate report for each animal (e.g., two kittens
received Drug X, a de-worming medication.
One vomited and wouldn't eat for several days,
while the other had a seizure).
Date of Onset: Provide the date when the
adverse event first started.

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Length of Time Between Exposure to
Suspected Product and Onset of Adverse
Event: Enter the length of time from the first
day the product was given to the onset of the
adverse event (e.g., 3 days).
Length of Time Between Last Administration
of Suspected Product(s) and Onset of
Adverse Event: Enter the length of time from
the last dose of the product to the onset of the
adverse event (e.g., 3 hours).
When the Reaction Occurred, Treatment with
Suspected Product:
Check the appropriate box that applies to the
reported adverse event. If “Other” is checked,
provide comments in narrative box at the end of
the form.

Concurrent Product Information:
Please
provide names, doses, and dates of treatments
for products that the patient was taking at the
time of the event. Do include over-the-counter
products, such as supplements, vitamins, and
homeopathic preparations.
Do not include
products used to treat the event. Check “None”
if nothing else was being given at the time of the
adverse event.
Adverse
Event/Product
Defect
(Long
Narrative): Use this space to describe the
event, possible contributing factors, and
outcome.
Include a description of what
happened and a summary of all available clinical
information.

Attached Document File Name:
If attaching any supporting documents, such as
letters, medical records, or photos, provide the
name of the file here.
Examples:
o

Documents for Princess.doc.

o

Spreadsheet
results.xls

o

Photographs of Princess before and after
treatment.jpg

o

Newspaper article about the product.pdf

of

Princess'

laboratory

If you mail your report, these attachments
should accompany the paper Form FDA 1932a.
Attached Document Description: If attaching
any supporting documents, provide the
description of the contents (e.g., medical
records, lab tests, photograph, newspaper
article, etc.)
Concurrent Clinical Problem(s):
Provide
information on other known health problems of
the patient at the time of exposure to the product
(e.g., chronic allergic dermatitis, intermittent
vomiting, allergic reaction following vaccination).
Check “None” if there are no known concurrent
problems.
FORM FDA 1932a (1/10)

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