Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4850

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001013

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.

02-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Extra Large Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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7. b) Type of formulation.

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 02-Jun-2023, a pet owner contacted Elanco regarding a possible adverse reaction and a perceived lack of efficacy to K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On approximately 01-May-2022, 01-Jun-2022, 01-Jul-2022, 01-Aug-2022, 01-Sep-2022, 01-Oct-2022 and 01-Nov-2022 the pet owner applied the product to the dog. On 21-May-2023 the pet owner once again applied the product to the dog.

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

Rottweiler

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

56.8

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 - Parasitism

• Nervous and Muscular Systems
  • Symptom - Lameness
  • Symptom - Difficulty getting up

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Difficulty walking

• General
  • Symptom - Parasitism
  • Specify - Borrelia burgdorferi

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?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 01-Aug-2022, the pet owner found a tick on the 6 year old, 56.8kg, neutered, male, Rottweiler dog (4 ticks were found in total throughout the summer but dates are unknown). On approximately 01-Sep-2022 the dog began vomiting, was limping, and unable to walk or rise (difficulty getting up). On approximately 01-Sep-2022 the dog was seen by a veterinarian and was prescribed an unknown medication. On approximately 02-Sep-2022 the dog was once again seen by the veterinarian and a Snap 4DX blood test was performed. The results came back as positive for Borrelia burgdorferi. The dog had never had a prior Snap 4DX test. The dog was prescribed an unknown medication. An unknown time after onset, the vomiting, limping, and inability to walk/rise, resolved. A Snap 4DX was not repeated. On 26-May-2023 the pet owner found an attached tick on the dog. On 28-May-2023 the pet owner found an attached tick on the dog. On 01-Jun-2023 the pet owner found another attached tick on the dog.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here