Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2807

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000887

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.

05-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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9 advantix II pipette size unknown

• 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.

Unknown

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 5 Apr 2024, Elanco was made aware of a suspected adverse reaction to K9 Advantix II (Permethrin, Imidacloprid, Pyriproxyfen) in a dog from a Professional Veterinary Association Newsletter. On an unknown date, the owner purchased K9 Advantix II at the clinic. The owner applied the product that day.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

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

• Renal System
  • Symptom - Renal failure

• General
  • Symptom - Malaise
  • Symptom - Death

• Renal System
  • Symptom - Other
  • Specify - Acute kidney injury

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 dog, of an unknown signalment and condition, with no known concomitant medical conditions, became ill (malaise). The owner bathed the dog but as its condition deteriorated, the patient was taken to the clinic where it was administered 1.0 ml of dexamethasone by a veterinary auxiliary without examination by the veterinarian. The patient was hospitalized. On an unknown date, blood work was done and revealed acute kidney injury and acute kidney failure. Treatment was with subcutaneous fluids and an injection of penicillin. The patient remained in hospital and its condition deteriorated. It was deceased the following day.

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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