Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4888

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001059

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-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

29-APR-23

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 6 Jun 2023, the attending veterinarian contacted Elanco regarding a possible adverse effect of K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On an unknown date the pet owner administered 1 tube of K9 Advantix ll Medium Dog to the dog. On 28 May 2023 the owner applied the dog's second dose of K9 Advantix ll.

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

Maltese (Canine/dog) crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.9

7. Weight (provide a range if necessary )

4.9

kg

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

• Skin
  • Symptom - Pruritus

• Ear
  • Symptom - Other
  • Specify - Pinnal reddening
  • Symptom - Other
  • Specify - Ear infection
  • Symptom - Other
  • Specify - Otitis

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 29 Apr 2023, the 1 year, 11 month old, 4.9 kg, neutered female, Maltese crossbreed dog had application site pruritus and was also scratching its ears. On 4 May 2023 a veterinary examination was sought. The ear pinnae were red and bilateral yeast ear infection was diagnosed. The dog was treated with Surolan 0.4 ml twice daily for 14 days. The application site pruritus was treated with Vitamin E. On 29 May 2023 the dog again had application site pruritus. The otitis was resolved with slight redness remaining on the pinnae. The dog was treated with trimeprazine tartrate-prednisolone for 6 days.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here