Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-3993

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_000980

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.

06-JUN-22

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

31-MAY-22

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 6 Jun 2022, the clinic's staff contacted Elanco regarding death in a dog following administration of K9 Advantix Extra Large dog (Permethrin, Imidacloprid, Pyriproxyfen). On 30 May 2022, the owner applied one dose of K9 Advantix II Extra Large dog 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

29

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Polydipsia

• Renal System
  • Symptom - Polyuria

• General
  • Symptom - Weakness

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Diarrhea

• Nervous and Muscular Systems
  • Symptom - Difficulty walking

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 31 May 2022 and 1 Jun 2022, the owner reported that the 8 year old, 29 kg, intact female, crossbred dog, with concomitant conditions of coughing, red and swollen eyes, multiple mammary tumors, neck stiffness, nasal congestion, gastric reflux, lethargy, panting, drinking more, and shortness of breath, who was being administered corticosteroids, famotidine, diphenhydramine, and possibly Advantage Multi, was anorexic. On 2 Jun 2022, the owner reported that the dog presented polydipsia and polyuria, weakness, vomiting, diarrhea and was unable to walk. The owner bathed the dog with an unknown shampoo. On 3 Jun 2022, the patient was found deceased. No necropsy was done.

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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