Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5748

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001421

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.

03-AUG-22

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

21-JUL-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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Medium 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.

1

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 03-Aug-2022, a clinic staff member contacted Elanco regarding an adverse event following the application of Advantage Multi 20 (Imidacloprid, Moxidectin) and K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 01-Jul-2022 the pet owner applied the Advantage Multi to the dog. The dog had no issues. On 21-Jul-2022 the pet owner applied the K9 Advantix II Medium 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

Cavalier King Charles Spaniel

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

7.3

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• Nervous and Muscular Systems
  • Symptom - Anxiety

• General
  • Symptom - Hiding

12. How long did the symptoms last?

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

Immediately after the K9 Advantix II application, the 3 year old, 7.3kg, neutered, male, Cavalier King Charles Spaniel dog, in unknown condition, with no known concomitant medical conditions, developed generalized pruritus, became anxious, and was hiding. The symptoms lasted 24 hours and the dog 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