Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-3280

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_000603

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.

19-APR-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

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 19-Apr-2023, a clinic staff member contacted Elanco regarding a possible adverse reaction to K9 advantix II pipette size unknown (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On an unknown date in 2021 and on 15-Apr-2023 the pet owner applied the product to the dog.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

crossbred Golden Retriever/ poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

22.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

12. How long did the symptoms last?

<=30 min / <=30 min

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

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

On an unknown date in 2021, 8 hours after application, the dog vomited once and recovered. On 15-Apr-2023, the now 2.5 year old, 22.6kg, neutered, female, Golden Retriever/Poodle crossbred dog in unknown condition with unknown concomitant medical conditions vomited once after 8 hours after application and immediately recovered without treatment.

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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