Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2823

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000973

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.

12-APR-24

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II 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.

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 12Apr2024, the attending veterinarian contacted Elanco to report an adverse reaction with K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen), involving extra label use, in a cat. The following was reported: On an unknown date in 2023 the pet owner applied the product K9 advantix II Large Dog to the cat. The product was not used correctly (Misuse species). 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

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

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

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

Fully Recovered / Complètement 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

An unknown time after application, the cat of unknown signalment developed tremors. On an unknown date the cat was examined by the veterinarian and prescribed Methocarbamol. On an unknown date the cat recovered. The attending veterinarian's suspicion that K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) has a causal association with the clinical signs is high.

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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