Fda 1932 Veterinary Adverse Drug Reaction, Lack Of Effectiveness,

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Veterinary Medicine

VETERINARY ADVERSE DRUG REACTION, LACK OF
EFFECTIVENESS, PRODUCT DEFECT REPORT
(Forward to address at right. Attach all correspondence that pertains to this reaction.)

Form Approved: OMB No. 0910-0284
Expiration Date: 7/31/2023
(See PRA Statement on page 9.)
Food and Drug Administration
7500 Standish Place (HFV-240)
Rockville, MD 20855-9921

NOTE: This report is required by law (21 CFR 514.80 and 512 (l) of the Federal Food, Drug, and Cosmetic Act (FDCA)).
Failure to report can result in withdrawal of approval of the application (21 CFR 514.80 (h) and 512 (e) of the FDCA).

The data elements marked with an asterisk [*] require a value or text to be entered. An asterisk at the section
level applies to all fields within that section. An asterisk at the subsection level applies to all fields
within that subsection. Otherwise, asterisks apply to individual fields.

Part A
Administrative and Identification Information
Regulatory Authority - RA (A.1)
RA Name (A.1.1)*

Street Address (A.1.2)*

City (A.1.3)*

State/County or Province (A.1.4)

Mail/Zip Code (A.1.5)*

3-Character Country
Code (A.1.6)*

Marketing Authorization Holder - MAH (A.2)
MAH Information (A.2.1)
Business Name (A.2.1.1)*

Street Address (A.2.1.2)*

City (A.2.1.3)*

State/County or Province (A.2.1.4)

3-Character Country
Code (A.2.1.6)*

Mail/Zip Code (A.2.1.5)*

Person Acting on Behalf of the MAH (A.2.2)
Title (e.g., Mr., Ms., Dr.)
(A.2.2.1)

First Name (A.2.2.2)

Telephone Number (A.2.2.4)

Last Name (A.2.2.3)

Fax Number (A.2.2.5)

Email Address (A.2.2.6)

Person(s) Involved in the AER (A.3)
Primary Reporter (A.3.1)
Primary Reporter Category (A.3.1.1)* (Select One)
Veterinarian

Animal Owner

Physician

Last Name (A.3.1.2)*
Telephone Number (A.3.1.4)
Business Name (A.3.1.7)
City (A.3.1.9)

FORM FDA 1932 (5/19)

Other Health Care Professional

Patient

Other

Unknown

First Name (A.3.1.3)
Fax Number (A.3.1.5)

Email Address (A.3.1.6)
Street Address (A.3.1.8)

State/County or Province (A.3.1.10)

Page 1

Mail/Zip Code (A.3.1.11)

3-Character Country
Code (A.3.1.12)*

PSC Publishing Services (301) 443-6740

EF

Part A - Administrative and Identification Information (Continued)
Person(s) Involved in the AER (A.3) (Continued)
Other Reporter (A.3.2)
Other Reporter Category (A.3.2.1)* (required if any of the A.3.2 information is provided) (Select One)
Veterinarian

Animal Owner

Physician

Other Health Care Professional

Patient

Other

Unknown

First Name (A.3.2.3)

Last Name (A.3.2.2)
Telephone Number (A.3.2.4)

Fax Number (A.3.2.5)

Email Address (A.3.2.6)

Business Name (A.3.2.7)

Street Address (A.3.2.8)

City (A.3.2.9)

State/County or Province (A.3.2.10)

3-Character Country
Code (A.3.2.12)

Mail/Zip Code (A.3.2.11)

AER Information (A.4)
Unique AER Identification Number (A.4.1)*:
Original Receive Date (A.4.2)* (dd/mm/yyyy)
Day

Month

Date of Current Submission (A.4.3)* (dd/mm/yyyy)

Year

Month

Day

Year

Type of Report (A.4.4)
Type of Submission (A.4.4.1)* (Select One)
Expedited

Periodic

Follow-up

Nullification

3-Day Field Alert

Other

Reason for Nullification Report (A.4.4.2) (provide if nullification is selected from A.4.4.1)

Type of Information in Report (A.4.4.3)

Part B
Description of the AE
Animal Data (B.1) (The fields within this section (B.1) are applicable only if an animal is associated with the report.)
Number of Animals Treated (B.1.1)

Number of Animals Affected (B.1.2)*

Attending Veterinarian’s Assessment of Animal Health Status Prior to VMP Use (B.1.2.1)

Species (B.1.3)*:

Breed (B.1.4)
Purebred Information (B.1.4.1)
Breed (B.1.4.1.1) of Animal 1

FORM FDA 1932 (5/19)

Breed (B.1.4.1.1) of Animal 2

Page 2

Breed (B.1.4.1.1) of Animal 3

Part B - Description of the AE (Continued)
Animal Data (B.1) (Continued)
Crossbred Information (B.1.4.2)
Breed (B.1.4.2.1)

Breed (B.1.4.2.1)

Reproductive Status (B.1.6) (Select One)

Gender (B.1.5) (Select One)
Female

Male

Breed (B.1.4.2.1)

Unknown

Mixed

Intact

Neutered

Mixed

Unknown

Female Physiological Status (B.1.7) (Select One)
Nonpregnant Lactating

Nonpregnant Nonlactating

Pregnant Lactating

Mixed

Not Applicable

Unknown

Pregnant Nonlactating

Weight (B.1.8)
Measured, Estimated, Unknown Weights
(B.1.8.1)*
Measured

Estimated

Minimum Weight in Kilograms (B.1.8.2)

Maximum Weight in Kilograms

(provide if Measured or Estimated selected from B.1.8.1) (B.1.8.3)

Unknown

Age (B.1.9)
Measured, Estimated, Unknown Age (B.1.9.1)*
Measured
Unknown
Estimated
Minimum Age (B.1.9.2) (provide if Measured or Estimated Minimum Age Units (B.1.9.2.1) (provide if B.1.9.2 is given) (Select One)
selected from B.1.9.1)

Day
Hour
Minute
Second
Month
Maximum Age Units (B.1.9.3.1) (provide if B.1.9.3 is given) (Select One)

Maximum Age (B.1.9.3)

Second

Minute

Hour

Day

Month

Year
Year

VMP(s) Data and Usage (B.2)
(For additional VMP(s), fill out appropriate B.2.1-B.2.6.5 entries on corresponding pages of additional forms.)
Registered or Brand Name (B.2.1)*

Product Code (B.2.1.1)

Registration Identifier (B.2.1.2)*

ATCvet Code (B.2.1.3)*

Company or MAH (B.2.1.4)
The following fields (B.2.1.5-B.2.1.7.1.3.3) are applicable only if an animal is associated with the report.
MAH Assessment (B.2.1.5)

RA Assessment (B.2.1.6)
RA Assessment Term (B.2.1.6.1)
Explanation Relating to Assessment (B.2.1.6.1.1)
Route of Exposure (B.2.1.7)

Dose Per Administration (B.2.1.7.1)
Numeric Value for Dose (Numerator) (B.2.1.7.1.1)

Units of Value for Dose (Numerator) (B.2.1.7.1.1.1) (provide if B.2.1.7.1.1 is given)

Numeric Value for Dose (Denominator) (B.2.1.7.1.2)

Units of Value for Dose (Denominator) (B.2.1.7.1.2.1) (provide if B.2.1.7.1.2 is given)

FORM FDA 1932 (5/19)

Page 3

Part B - Description of the AE (Continued)
VMP(s) Data and Usage (B.2) (Continued)
Interval of Administration (B.2.1.7.1.3)
Units of Value for Interval of Administration (B.2.1.7.1.3.1.1)

Numeric Value for Interval of Administration
(B.2.1.7.1.3.1)

(provide if B.2.1.7.1.3.1 is given) (Select One)

Second
Date of First Exposure (B.2.1.7.1.3.2) (dd/mm/yyyy)
Day

Month

Minute

Hour

Day

Month

Year

Date of Last Exposure (B.2.1.7.1.3.3) (dd/mm/yyyy)

Year

Day

Month

Year

Active Ingredient(s) (B.2.2)
1st Entry
Active Ingredient(s) (B.2.2.1)*

Numeric Value for Strength (Numerator) (B.2.2.1.1)*

Units for Numeric Value for Strength (Numerator) (B.2.2.1.1.1)*

Numeric Value for Strength (Denominator) (B.2.2.1.2)*

Units for Numeric Value for Strength (Denominator) (B.2.2.1.2.1)*

Active Ingredient Code (B.2.2.1.3):

2nd Entry
Active Ingredient(s) (B.2.2.1)*

Numeric Value for Strength (Numerator) (B.2.2.1.1)*

Units for Numeric Value for Strength (Numerator) (B.2.2.1.1.1)*

Numeric Value for Strength (Denominator) (B.2.2.1.2)*

Units for Numeric Value for Strength (Denominator) (B.2.2.1.2.1)*

Active Ingredient Code (B.2.2.1.3):

3rd Entry
Active Ingredient(s) (B.2.2.1)*

Numeric Value for Strength (Numerator) (B.2.2.1.1)*

Units for Numeric Value for Strength (Numerator) (B.2.2.1.1.1)*

Numeric Value for Strength (Denominator) (B.2.2.1.2)*

Units for Numeric Value for Strength (Denominator) (B.2.2.1.2.1)*

Active Ingredient Code (B.2.2.1.3):
Dosage Form (B.2.2.2)
Lot Number (B.2.3)

Expiration Date (B.2.3.1) (dd/mm/yyyy)
Day

FORM FDA 1932 (5/19)

Page 4

Month

Year

Part B - Description of the AE (Continued)
VMP(s) Data and Usage (B.2) (Continued)
The following fields (B.2.4-B.2.5.1) are applicable only if an animal is associated with the report.
Who Administered the VMP? (B.2.4) (Select One)
Veterinarian

Animal Owner

Other Health Care Professional

Physician

Patient

Other

Unknown

Multiple Administrators

Use According to Label (B.2.5) (Select One)
Yes

No

No Information
Explanation for the Off-Label Use Code (B.2.5.1) (Select All That Apply)

Was the target species Off-Label (B.2.5.1.1)
No

Yes

Was the indication Off-Label (B.2.5.1.6)

No Information

Yes

Was the route of administration Off-Label (B.2.5.1.2)
No

Yes

No Information

Was the animal overdosed (B.2.5.1.3)
No

Yes

No

No Information

Yes

No

No Information

Was the product expired (B.2.5.1.8)

No Information

Was the animal underdosed (B.2.5.1.4)
Yes

No

Was the storage condition Off-Label (B.2.5.1.7)

No Information
Yes
No
Was there any other Off-Label issue (B.2.5.1.9)
Yes

No Information

No

No Information

Was the treatment regime Off-Label (B.2.5.1.5)
No

Yes

No Information

Product/Manufacturing Defect Information (B.2.6)
The fields within this subsection (B.2.6.1-B.2.6.5) are applicable only if reporting a product/manufacturing defect.
Manufacturing Site Identifier Number (B.2.6.1)

Manufacturer’s Identifier Type (B.2.6.1.1) (select one if B.2.6.1 is given)
FEI Number

Manufacturing Date (B.2.6.2) (dd/mm/yyyy)
Day

Month

Year

Number of Defective Items (B.2.6.3)

Defective Item Units (B.2.6.3.1)

Number of Items Returned (B.2.6.4)

Returned Item Units (B.2.6.4.1)

ORA District Field Office (B.2.6.5)

AE Data (B.3)
Narrative of AE (B.3.1)*

FORM FDA 1932 (5/19)

Page 5

DUNS Number

Part B - Description of the AE (Continued)
AE Data (B.3) (Continued)
Narrative of AE (B.3.1)* (Continue, if needed)

Adverse Clinical Manifestations (B.3.2)*

FORM FDA 1932 (5/19)

Number of Animals (B.3.2.1)

Page 6

Accuracy of the Number of Animals
(B.3.2.1.1)
Actual

Estimated

Actual

Estimated

Actual

Estimated

Actual

Estimated

Actual

Estimated

Actual

Estimated

Part B - Description of the AE (Continued)
AE Data (B.3) (Continued)
Date of Onset of AE/PP Found Date (B.3.3)* (dd/mm/yyyy)
Month

Day

Year

The following fields (B.3.4-B.5.1) are applicable only if an animal is associated with the report.
Length of Time Between Exposure to VMP(s) and Onset of AE (B.3.4) (Select One)
<2 Minutes

<24 Hours

<7 Days

>30 Days and <6 Months

<1 Hour

<48 Hours

<14 Days

>6 Months and <12 Months

<12 Hours

<3 Days

<30 Days

>12 Months

Unknown

Duration of AE (B.3.5)
Duration Time Units (B.3.5.1.1) (provide if B.3.5.1 is given) (Select One)

Duration (B.3.5.1)

Month

Year

Treatment of AE (B.3.7) (Select One)

Serious AE (B.3.6)* (Select One)
Yes

Day

Hour

Minute

Second
No

Yes

No

Unknown

No Information

Outcome to Date (B.3.8) (Enter appropriate numbers where applicable)
Ongoing (B.3.8.1)

Recovered/Normal (B.3.8.2)

Recovered with Sequela (B.3.8.3)

Died (B.3.8.4)

Euthanized (B.3.8.5)

Unknown (B.3.8.6)

Previous Exposure to the VMP? (B.3.9) (Select One)
Yes

No

Unknown

Previous AE to the VMP? (B.3.10) (Select One)

No Information

Yes

No

Unknown

No Information

Dechallenge - Rechallenge Information (B.4)
Did AE Abate After Stopping the VMP? (B.4.1) (Select One)
Yes

No

Unknown

No Information

Not Applicable

Did AE Reappear After Re-introduction of the VMP? (B.4.2) (Select One)
Yes

No

No Information

Unknown

Not Applicable

Assessment of AE (B.5)
Attending Veterinarian’s Assessment (B.5.1) (Select One)
Probable

Possible

Unlikely

No Assessment

Unknown

No Attending Veterinarian

Report Number(s) of Linked Report(s) (B.6)
Unique AER Identification Number (B.6.1)

Explanation for Linkage (B.6.1.1) (provide if B.6.1 is given) (Select One)
Parent - Offspring

Same patient

Similar reports from same reporter (cluster)

Duplicate report

Other link type

Supplemental Documents (B.7)
Attached Document Name(s) (Filename(s) if Electronic) (B.7.1)

FORM FDA 1932 (5/19)

Attached Document Type(s) (B.7.1.1) (provide if B.7.1 is given)

Page 7

Part B - Description of the AE (Continued)
HL7 ICSR Wrapper Data Elements (B.8)
Only sections B.8.2.2.3-B.8.2.2.8, B.8.2.5, and B.8.2.6 are relevant for submission of the paper form.
Batch Wrapper (B.8.1)
Batch Number/Identifier (B.8.1.1)*

Batch Number/Identifier - Root (B.8.1.1.1)

Batch Number/Identifier - Extension (B.8.1.1.2)

Not Applicable for Paper Form

Not Applicable for Paper Form

Batch Sender (B.8.1.2)

Batch Sender - Root (B.8.1.2.1)*

Batch Sender - Extension (B.8.1.2.2)*

Not Applicable for Paper Form

Not Applicable for Paper Form

Batch Sender - Title (B.8.1.2.3)
Not Applicable for Paper Form

Batch Sender - Last Name (B.8.1.2.4)*

Batch Sender - First Name (B.8.1.2.5)*

Batch Sender - Telephone (B.8.1.2.6)*

Batch Sender - Fax (B.8.1.2.7)

Not Applicable for Paper Form

Not Applicable for Paper Form

Not Applicable for Paper Form

Not Applicable for Paper Form

Batch Sender - Email (B.8.1.2.8)*
Not Applicable for Paper Form

Batch Receiver (B.8.1.3)
Batch Receiver - Root (B.8.1.3.1)*

Batch Receiver - Extension (B.8.1.3.2)

Date of Batch Creation (B.8.1.4)* Not Applicable for Paper Form

VICH AER Version Number (B.8.1.5)*

USFDA

Day

Month

US Food and Drug Administration

VICH AER 1.0.0

Year

Message Number - Root (B.8.2.1.1)

Transmission Wrapper (B.8.2)
Message Number (B.8.2.1)*

Message Number - Extension (B.8.2.1.2)

Not Applicable for Paper Form

Not Applicable for Paper Form

Pharmacovigilance Contact Person for the MAH (Message Sender) (B.8.2.2)
Message Sender - Root (B.8.2.2.1)

Message Sender - Extension (B.8.2.2.2)

Not Applicable for Paper Form

Not Applicable for Paper Form

Title (Message Sender - Title) (B.8.2.2.3)
Last Name (Message Sender - Last Name) (B.8.2.2.4)*

First Name (Message Sender - First Name) (B.8.2.2.5)*

Telephone (Message Sender - Telephone) (B.8.2.2.6)*

Fax (Message Sender - Fax) (B.8.2.2.7)

Email (Message Sender - Email) (B.8.2.2.8)*

Message Receiver (B.8.2.3)
Message Receiver - Root (B.8.2.3.1)*

Date of Message Creation (B.8.2.4)* Not Applicable for Paper Form

USFDACVM

Report Identifier (B.8.2.5)*

Day
Domestic

Foreign - Same

Profile Identifier (B.8.2.7)* Not Applicable for Paper Form (Select One)
Adverse Event

FORM FDA 1932 (5/19)

Month

Year

Domestic vs. Foreign Report Category (B.8.2.6)* (Select One)

Adverse Event and Product Problem

Page 8

Product Problem

Other

Foreign - Similar

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FORM FDA 1932 (5/19)

Page 9