Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2277

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000673

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.

18-MAR-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

18-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. 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 18Mar2024, a pet owner contacted Elanco via phone call to inquire about the expiry date of K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) and inadvertently reported an adverse reaction with K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 17Mar2024, the pet owner applied 1 tube of K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) to a 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Retriever - Labrador

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

36.36

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

12. How long did the symptoms last?

>30 min <=2 hrs / >30 min <=2 h

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 18Mar2024, the 11 year old, 36.36 kilogram, neutered male, Labrador Retriever, vomited bile one time. One hour after onset the dog recovered without treatment. The dog was not examined by a veterinarian.

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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