Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-0034

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001980

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-OCT-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II 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.

2.5

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 18-Oct-2022, a clinic staff member contacted Elanco regarding a possible adverse reaction to K9 Advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 10-Sep-2022 the pet owner applied the product to the dog (misuse overdose).On 10-Oct-2022, the pet owner again applied 1 tube/pipette of K9 Advantix II Large Dog topically to the dog (misuse: overdose).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Greyhound - Italian/Unknown Crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

10

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
  • Symptom - Hair loss

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• Skin
  • Symptom - Itchy skin

• Ear
  • Symptom - Other
  • Specify - Ear twitching

12. How long did the symptoms last?

Unknown / Inconnu

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 unknown date, the 5 year old, 10kg, neutered, male, Italian Greyhound crossbred dog, in unknown condition, with no known concomitant medical conditions, had generalized pruritus and hair loss on his shoulders (not at the application site). On unknown date after onset the pet owner bathed the dog with an unknown shampoo. Immediately after the bath the dog recovered without treatment. On 12-Oct-2022, after the second application of K9 Advantix II, the dog had ear twitching and itchy ears (itchy skin). On 13-Oct-2022, the pet owner bathed the dog with an unknown shampoo and gave the dog an unknown dose of Diphenhydramine orally. On 17-Oct-2022 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

Moderate

19. Provide supplemental information here