Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4680

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2022_032803

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court, Suite 401

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.

11-JUL-22

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. 11556-143

Product Name: K9 Advantix II Large 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.

2.5

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 11 Jul 2022 an animal owner posted online regarding an adverse event after using K9 Advantix II Large Dog on their cat/feline and reported the following: On an unknown date, a cat was administered 1 dose of K9 Advantix II Large Dog (imidacloprid, permethrin, pyriproxyfen) topically by the owner. No concomitant products were administered.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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

• Gastrointestinal System
  • Symptom - Diarrhea

• Nervous and Muscular Systems
  • Symptom - Convulsions

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 male feline/cat, of an unknown signalment and condition, with unknown concomitant medical conditions, had severe diarrhoea. They took the cat to the veterinarian and the veterinarian did not know that this was the issue until they administered other unspecified medications. The cat died on an unknown date after convulsions, vomiting, and diarrhoea. The owner stated the product was responsible.

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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