Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4716

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_029893

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L5N 0C9

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

14-JUN-23

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-141

Product Name: K9 Advantix II Small Dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

Units: mL

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On 14 Jun 2023, Elanco was contacted by an animal owner regarding an inquiry and mentioned a potential adverse event with using the K9 Advantix II on their dog. On an unknown date, a dog had 1 tube of K9 Advantix II (imidacloprid/ permethrin/ pyriproxyfen) small dog placed on his neck, topically, by the owner, for prevention and treatment of fleas, ticks, mosquitoes, biting flies, and lice. Frequency of product administration was unknown.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

3.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Cardiovascular System
  • Symptom - Heart murmur
  • Symptom - Other
  • Specify - Heart failure

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On an unknown date, the 14 year old, 3.6 kg, neutered male, Chihuahua dog was diagnosed with a heart murmur. On an unspecified date, the dog's heart gave out and he passed away. The caller was not attributing the clinical signs or death to the product.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here