Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5556

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001455

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-JUL-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-JUL-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. 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 Jul 2023 a pet owner contacted Elanco to report a possible adverse event regarding K9 Advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On approximately 30 Jun 2023 was administered 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner.

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

Chein Francais Tricolore

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

12.3

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Skin
  • Symptom - Red skin
  • Symptom - Dry skin
  • Specify - Flaking skin
  • Symptom - Hair loss
  • Symptom - Lesion
  • Specify - Scabs

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 approximately 02 Jul 2023, the 4 month old, 12.3 kg, intact, female, Chein Francais Tricolore dog, in unknown condition, with no known concomitant medical conditions, had redness, flaky skin, hair loss and scabs at the application site. On approximately 10-Jul-2023 the owner had examined the pet and was prescribed unknown medications. On approximately 17 Jul 2023 the dog recovered from the flaky skin, hair loss and scabs. The redness at the application site continued. Multiple unsuccessful attempts to gather follow up information were made. Outcome unknown.

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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