Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4729

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_031894

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court

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.

22-JUN-23

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

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. 11556-141

Product Name: K9 Advantix II Small Dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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7. b) Type of formulation.

Liquid

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 22 Jun 2023, an animal owner contacted Elanco and reported the following: On unknown dates, a dog in unknown condition with no known medical concerns was administered one tube of the K9 Advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the animal owner for flea and tick prevention. It is unknown if any concomitant products were administered. The owner stated that the dog had been on K9 Advantix II Small Dog her whole life.

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

Terrier - Yorkshire

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

4

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

• General
  • Symptom - Death

• Cardiovascular System
  • Symptom - Other
  • Specify - Heart failure

• Renal System
  • Symptom - Renal failure

• Gastrointestinal System
  • Symptom - Weight loss

12. How long did the symptoms last?

Persisted until death

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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 dates, the 16-year-old, about 4 kg, female spayed Yorkshire Terrier dog, in unknown condition, with no known medical concerns, had lost a little weight, developed heart failure and kidney failure, and died of natural causes. The owner did not attribute any of the adverse events to K9 Advantix II Small Dog.

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To be determined by Registrant

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

Death

19. Provide supplemental information here