Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2269

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000555

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.

07-MAR-24

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

06-MAR-24

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Medium 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.

1

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 7 Mar 2024, an attending veterinarian contacted Elanco regarding a possible adverse event involving K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog and reported the following: On 6 Mar 2024, the pet owner administered a dose of K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically to a dog (misuse: overdose). This was a first time use of the product.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Golden Retriever/ Poodle crossbred dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

4.1

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

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Pruritus

• Nervous and Muscular Systems
  • Symptom - Shaking

• General
  • Symptom - Abnormal behaviour
  • Specify - Rolling

• Nervous and Muscular Systems
  • Symptom - Insomnia

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non rétabli

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 6 Mar 2024, an unknown time after application of K9 Advantix II, the 2 year old, 4.1 kg, neutered female, crossbred Golden Retriever/ Poodle dog, became agitated, pruritic, was shaking, rolling, and scratching (pruritus). The owner attempted to remove the product from the dog's skin with water and oatmeal. On 7 Mar 2024 a veterinary examination was sought. The owner reported the dog had not slept much (insomnia). The veterinarian reported that no abnormalities were found on physical examination.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here