Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-7216

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_056351

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.

18-OCT-23

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

08-JUL-23

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. 11556-144

Product Name: K9 Advantix II Extra 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.

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 18-Oct-2023, an animal owner contacted Elanco regarding an adverse event and flea lack of efficacy while using K9 Advantix II Extra Large Dog on their dog and reported the following: On approximately 01-Jul-2023, a dog had 1 tube of K9 Advantix II Extra Large Dog (Over 55 lbs) (Imidacloprid-Permethrin-Pyriproxyfen) applied via the topical route by the animal owner. The product was used correctly.

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

Great Dane

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

56.69

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• General
  • Symptom -
  • Specify - Unspecified blockage
  • Symptom - Death
  • Symptom - Parasitism

12. How long did the symptoms last?

Unknown / Inconnu

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 approximately 08-Jul-2023, live fleas were visualized on the approximately 1 year old, approximately 56.69 kg, intact, female, Great Dane dog, in unknown condition, that had no known concomitant medical conditions. On approximately 15 Jul 2023 the dog was bathed with an unspecified shampoo. On approximately 16-Jul-2023, the dog experienced an unspecified blockage and died. It is not known if the dog was evaluated by a veterinarian or if any treatments were performed.

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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